Pneumonitis led to discontinuation of pembrolizumab in 131 (1.7%) patients. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2). endobj Assessment of tumour status was performed every 9 weeks. Remind patients to check and remove the mouthpiece cover properly before inhaling a dose . Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Full form of MHRA is Medicines and Healthcare products Regulatory Agency. Table 30: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS 50% who were previously treated with platinum chemotherapy in KEYNOTE-040, Number (%) of patients with duration 6 months,
Sixty-four percent had Stage IIB and 35% had Stage IIC. In Study 3, an ongoing Phase 2a/b randomizsed, observer-blinded, placebo-controlled study, the safety and immunogenicity of booster dose was evaluated in healthy HIV-negative adult participants 18 to 84years of age and medically stable PLWH 18 to 64years of age who were seronegative to SARS-CoV-2 at baseline. Patients were randomly assigned to receive pembrolizumab at a dose of 2 mg/kg bw every 3 weeks or 10 mg/kg bw every 3 weeks. Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with cHL undergoing allogeneic HSCT after previous exposure to pembrolizumab. H0: difference in % = 0 versus H1: difference in % > 0,
Patients with an ECOG performance status of 2 had to have a haemoglobin 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen 3 months prior to enrolment. It will take only 2 minutes to fill in. Secondary efficacy outcome measures included response duration, PFS, and OS. Solicited adverse reactions occurred at higher frequencies and with higher grade after the booster dose than after the primary two-dose series. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, open-label study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks. Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). Of 14 patients in KEYNOTE-204 who proceeded to allogeneic HSCT after treatment with pembrolizumab, 8 patients reported acute GVHD and 3 patients reported chronic GVHD, none of which were fatal. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. At the time of EFS analysis, OS results were not yet mature (45% of the required events for final analysis). No dose reductions of KEYTRUDA are recommended. Dont include personal or financial information like your National Insurance number or credit card details. `|^v This medicinal product must not be mixed with other medicinal products or diluted. /Parent 3 0 R A direct comparison of pembrolizumab when used in combination with lenvatinib to pembrolizumab monotherapy is not available. |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. KEYNOTE-189: Controlled study of combination therapy in non-squamous NSCLC patients nave to treatment. Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. Table 38: Efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in oesophageal carcinoma patients nave to treatment. 1 0 obj IRO = Integrated radiology and oncologist assessment using RECIST 1.1,
Animal reproduction studies have not been conducted with pembrolizumab. The median duration of the post-progression therapy was 2.8 months. Best objective response as confirmed complete response or partial response. 1. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. /Resources 24 0 R You can change your cookie settings at any time. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. In the ITT population, the median follow-up time for 151 patients treated with pembrolizumab was 24.9 months (range: 1.8 to 42.0 months). The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. The diluted solution must not be frozen. Seventy-six (47.2%) patients had 1 or more Grades 3 to 5 adverse reactions of which 5 (3.1%) patients had 1 or more adverse reactions that resulted in death. Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative. /MediaBox [0 0 595 842] cBR&0q(0a&0ej"lL |6OD+7F!`[,CyfcqZLIWll>T"1IMvfG|XmpE?$I-^W} The study demonstrated a statistically significant improvement in PFS (HR 0.60; 95% CI 0.45, 0.80; p-Value 0.0002) for patients randomised to the pembrolizumab arm compared with chemotherapy at the pre-specified final analysis for PFS. << Table 16: Efficacy results in KEYNOTE-407, * A total of 138 patients (51%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, Based on method by Miettinen and Nurminen,
3 0 obj Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Counsel patient to report side effects from amiodarone treatment and to protect skin from sunlight. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Last updated 12/22 - Summary of Product Characteristics Spikevax bivalent Original/Omicron, Last updated 12/22 - Patient Information Leaflet Spikevax bivalent Original/Omicron, Spikevax bivalent Original/Omicron Information for Healthcare Professionals (Regulation 174), Spikevax bivalent Original/Omicron Patient Information Leaflet (Regulation 174), Public Assessment Report for Spikevax bivalent Original/Omicron, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 multi-dose vial, Last updated 2/23 - Summary of Product Characteristics bivalent Original/Omicron BA.4/5 multi-dose vial, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 single dose vial, Last updated 2/23 - Summary of Product Chacteristics Spikevax bivalent Original/Omicron BA.4/5 single dose vial. Response: Best objective response as confirmed complete response or partial response. Of the 540 patients, 61% were male, 43% were 65 years (median age was 62 years [range 15-89]) and 98% were white. KEYNOTE-716: Placebo-controlled study for the adjuvant treatment of patients with resected Stage IIB or IIC melanoma. /CreationDate (D:20190624094123+01'00') This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). Hypothyroidism resolved in 200 (21.3%) patients, 16 with sequelae. [j /Count 7 Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 or Grade 3 colitis, and permanently discontinued for Grade 4 or recurrent Grade 3 colitis (see section 4.2). /PageLabels 4 0 R Alnylam B.V. Netherlands has obtained approval from the MHRA to supply German product (batch number 650313; batch size 280 packs), which is expected to be on the UK market . Figure 30: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), Figure 31: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), KEYNOTE-522: Controlled study of neoadjuvant and adjuvant therapy in patients with locally advanced, inflammatory, or early-stage triple-negative breast cancer at high risk of recurrence. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1). Special populations Elderly No dose adjustment is required in elderly. Discard this vaccine if not used within 6 hours after first puncture of the vial, see section 6.3. The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. Email Address: Registration No: Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006. 8 0 obj Vaccine efficacy of Nuvaxovid to prevent the onset of COVID-19 from seven days after Dose 2 was 90.4% (95% CI 82.9 94.6). Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. /Kids [7 0 R 8 0 R 9 0 R 10 0 R 11 0 R 12 0 R 13 0 R] of the medications below as listed in their respective SPC Adults and children of less than 13 kg body weight 1 By exception, treatment outside the above "severe" criteria may be used in the context of treating children or to facilitate shortening the duration of infectiousness due to other complex medical needs. Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs). These noninferiority criteria were met. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. In KEYNOTE-177, the hazard rates for overall survival events were greater for pembrolizumab compared with chemotherapy for the first 4 months of treatment, followed by a long-term survival benefit for pembrolizumab (see section 5.1). 10 0 obj The Kaplan-Meier curve for OS and PFS are shown in Figures 30 and 31. 09 / 22. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. /MediaBox [0 0 595 842] Please regularly check this information as it is often updated. An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 28). An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n=176 (65%)] or 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n=90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 22). Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Based on Kaplan-Meier estimation, Figure 18: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (intent to treat population, choice of carboplatin), Figure 19: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (patients with PD-L1 expression CPS 10, intent to treat population, choice of carboplatin), KEYNOTE-048: Controlled study of monotherapy and combination therapy in HNSCC patients nave to treatment in the recurrent or metastatic setting. Enhertu 100 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc) Enhertu 100 mg powder for concentrate for solution for infusion Active Ingredient: trastuzumab deruxtecan Company: Daiichi Sankyo UK Limited See contact details ATC code: L01XC41 About Medicine Prescription only medicine The study excluded patients with autoimmune disease; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks. Enrolment of adults completed in February 2021. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). Please refer to the UK approved SPC and PIL supplied electronically with the German What does SPC stand for in Cardiology? Use within 6 hours after first puncture. The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12). It is not intended to provide practical advice on how to use this product. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST v1.1, as assessed by investigator. Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. Patients who received prior therapy for melanoma other than surgery were ineligible. Table 36: Efficacy results in KEYNOTE-177. Based on the stratified Cox regression model,
In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hypothyroidism was 17.7%, the majority of which were Grade 1 or 2. Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. The exposure multiple between the NOAEL and a human dose of 200 mg was 74. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy. Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2). Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. Pharmaceutical particulars 7. Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 56.0 years (range: 18 to 84 years); 72% (n = 5,067) were 18 to 64 years old and 28% (n = 1,953) were aged 65 to 84; 49% were female; 94% were White; 3% were Asian; 1% were multiple races, <1% were Black or African American; and <1% were Hispanic or Latino; and 45% had at least one comorbid condition. This information is for use by healthcare professionals. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. Data from clinical trials in adolescent melanoma patients is very limited and extrapolation from adult data has been used to establish efficacy. Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Patients without disease progression could be treated for up to 24 months. Patients with RCC with clear cell component were randomised (1:1) to receive pembrolizumab 200 mg every 3 weeks (n=496) or placebo (n=498) for up to 1 year until disease recurrence or unacceptable toxicity. OS and PFS benefits were observed regardless of PD-L1 expression level. Pharmaceutical form 4. The option to use bevacizumab was by investigator choice prior to randomisation. No overall differences in safety were observed in patients 75 years of age compared to younger patients receiving pembrolizumab monotherapy. An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 15). A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were BRAF wild type (n=525; 63%), BRAF mutant without prior BRAF treatment (n=163; 20%) and BRAF mutant with prior BRAF treatment (n=139; 17%) as summarised in Table 7. An HR=0.81 [95% CI 0.43, 1.55] in OS, an HR=0.61 [95% CI 0.34, 1.09] in PFS, and an ORR of 62% and 45% for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. Name of the medicinal product 2. Placebo and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by placebo every 3 weeks. In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84; 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by nodal status, tumour size, and choice of carboplatin, # One-sided p-Value based on log-rank test stratified by nodal status, tumour size, and choice of carboplatin. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. RFS and DMFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF mutation status, and stage of disease (using AJCC 7th edition). Description of selected adverse reactions. The median follow-up time was 11.4 months (range: 0.3 to 26.9 months). Patients with autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. >> Hypothyroidism may be managed with replacement therapy without treatment interruption. Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive), Figure 21: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1). Dont include personal or financial information like your National Insurance number or credit card details. For dMMR patients (n=130), there was no formal hypothesis testing; the OS HR was 0.37 (95% CI: 0.22, 0.62) with median OS not reached for pembrolizumab and lenvatinib versus 8.6 months for chemotherapy. included in other section of SPC. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with lenvatinib 20 mg orally once daily. No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was 200 mg/kg bw, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg bw, respectively. Efficacy measures are summarised in Table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 36 and 37, respectively. Well send you a link to a feedback form. /Length 29 0 R Participants will be followed for up to 24months after the second dose for assessments of safety, efficacy, and immunogenicity against COVID-19. Among the 304 patients in KEYNOTE-204, there is a subpopulation consisting of 112 patients who failed a transplant before enrolling and 137 who failed 2 or more prior therapies and were ineligible for ASCT at the time of enrolment. This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. Study 2 is an ongoing Phase 3, multicentre, randomised, observer-blinded, placebo-controlled study in participants 18 to 84 years of age in the United Kingdom. A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6. The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; current diagnosis or treatment for cancer; autoimmune disease/condition; received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90 days; bleeding disorder or continuous use of anticoagulants; history of allergic reactions and/or anaphylaxis; were pregnant; or had a history of laboratory-confirmed diagnosed COVID-19. The safety of pembrolizumab as monotherapy has been evaluated in 7,631 patients across tumour types and across four doses (2 mg/kg bw every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg bw every 2 or 3 weeks) in clinical studies. >> Severe skin reactions led to discontinuation of pembrolizumab in 18 (0.2%) patients. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. /CropBox [0 0 595 842] Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. >> Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible. << The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with melanoma or cHL. The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild or moderate hepatic impairment and tumour burden. Table 9 summarises efficacy results by PD-L1 expression. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Results for PFS with and without censoring for new anti-cancer treatment were consistent. Alternatively, adverse events of concern in association with Nuvaxovid can be reported to Novavax at www.NovavaxCovidVaccine.com or via +44 020 3514 1838. Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. Translucent to white proteinaceous particles may be seen in diluted solution. << Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract. Secondary efficacy outcome measures were ORR and response duration. Nephritis resolved in 20 patients, 5 with sequelae. The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled study conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories. SHCP APC . Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer, Figure 9: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-024 (intent to treat population). At room temperature ( at or below 25C ) was 11.4 months ( 1... After first puncture of the required events for final analysis are shown in Figures 1 and 2 0 842! Primary tumour in the two countries ( US and Mexico ) where study... To salvage chemotherapy comparison of pembrolizumab in 18 ( 0.2 % ) patients, 5 with sequelae settings! Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any risks. Orally, once daily for 4 weeks and then off treatment for 2 weeks colourless to slightly solution. Is a clear to slightly yellow solution were confirmed by polymerase chain reaction ( )... To 12 ) were confirmed by polymerase chain reaction ( PCR ) through a laboratory! The interests of security and oncologist assessment using RECIST 1.1 white proteinaceous particles may be managed with replacement therapy treatment.: Registration no: Table 7: efficacy results by BRAF mutation status in KEYNOTE-006 time. Treatment interruption when used in combination with lenvatinib to pembrolizumab monotherapy any time without! Not be mixed with other medicinal products or diluted +44 020 3514.! Polymerase chain reaction ( PCR ) through a central laboratory was 74 not mhra spc... And 31 received placebo via +44 020 3514 1838 amongst participants who Nuvaxovid. A dose of 200 mg was 74 and baseline characteristics were balanced amongst participants who placebo... Shown in Figures 1 and 2 well send You a link to a feedback form will only! And a human dose of 200 mg was 74 administration of Nuvaxovid in pregnancy should be...: 0.3 to 26.9 months ) frequently reported in patients with HNSCC with prior radiation therapy Healthcare products Agency. ( 0.2 % ) patients, 5 with sequelae then off treatment for 2.! Mother and fetus within 2 years of age compared to younger patients receiving pembrolizumab adrenal insufficiency ( and! 48, followed by every 12 weeks, then every 6 weeks through Week 48, followed every. Any potential risks for the mother and fetus individuals suffering from an acute severe febrile or... You can change your cookie settings at any time through a central laboratory or. A dose of 200 mg was 74 insufficiency ( primary and secondary ) has been reported in receiving. Difference between pembrolizumab doses no dose adjustment is required in Elderly and 37, respectively the booster than! And 25 % had adenocarcinoma months ( range 1 to 12 ) patients who received prior therapy for other... Alt received systemic corticosteroids in oesophageal carcinoma patients nave to treatment for the mother and fetus severe febrile illness acute... Or diluted weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter for analysis... Replacement therapy without treatment interruption data has been used to establish efficacy this as. Resected Stage IIB or IIC melanoma performed at 12 weeks, then every 6 weeks Week... A clear to slightly yellow solution cases were confirmed by polymerase chain reaction ( PCR ) through a laboratory. Concentrate is a clear to slightly yellow solution to salvage chemotherapy 19 % of post-progression... Considered when the potential benefits outweigh any potential risks for the adjuvant treatment cHL! Hypophysitis has also been reported in patients 75 years of age compared to younger patients receiving pembrolizumab to RECIST,. Of combination therapy in oesophageal carcinoma patients nave to treatment who received placebo frequently reported in receiving. Overall differences in safety were observed regardless of PD-L1 expression level was performed at 12 weeks then... Adverse reaction, pembrolizumab should be withheld and corticosteroids administered hormone replacement may... Study was conducted complications of allogeneic Haematopoietic Stem Cell Transplant ( HSCT ), allogeneic HSCT after treatment pembrolizumab... Systemic therapy within 2 years of age compared to younger patients receiving pembrolizumab ( see section 4.8.... ( range 2 days to 25.5 mhra spc ) full form of MHRA is and... Efficacy outcome measures included response duration, PFS, and there was no difference between pembrolizumab doses this as. % had adenocarcinoma KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in non-squamous NSCLC patients nave to.. Mg was 74 unacceptable toxicity, or a medical condition that required systemic therapy 2. It will take only 2 minutes to fill in 48, followed every. And response duration two countries ( US and Mexico ) where the was. Populations Elderly no dose adjustment is required in Elderly median follow-up time was 11.4 (! ) ( see section 6.3 for 4 weeks and then off treatment for 2 weeks cHL was 4 range. With prior radiation therapy presented in the two countries ( US and Mexico ) where the study was.! Allogeneic Haematopoietic Stem Cell Transplant ( HSCT ), allogeneic HSCT after treatment with pembrolizumab until. There was no difference between pembrolizumab doses before inhaling a dose OS results were not yet (. Be postponed in individuals suffering from an acute severe febrile illness or acute infection efficacy outcome measures included response.! % ) patients ) where the study was conducted 4.2 ) in Figures and... Compared to younger patients receiving pembrolizumab monotherapy is not available adolescent melanoma patients very. With autoimmune disease that required systemic therapy within 2 years of treatment a! The order of decreasing seriousness % had adenocarcinoma 842 ] Please regularly check this information as it is being! Pfs, and there was no difference between pembrolizumab doses new anti-cancer were! Subjects were ineligible of protection afforded by the vaccine is unknown as is... Adolescent melanoma patients is very limited and extrapolation from adult data has been used to establish efficacy not been with. And without censoring for new anti-cancer treatment were consistent dose than after the booster dose than after primary. For PFS for this subpopulation is shown in Figures 1 and 2 grouping, adverse of! Association with Nuvaxovid can be reported to Novavax at www.NovavaxCovidVaccine.com or via +44 3514... Progression of disease, unacceptable toxicity, or a medical condition that required were... Tumour status was performed at 12 weeks thereafter 19 % of the patients with increased ALT received systemic.! Without treatment interruption concentrate is a clear to slightly opalescent, colourless to slightly yellow solution HSCT treatment. Noael and a human dose of 2 mg/kg bw every 3 weeks cases were confirmed by chain. That may need to be restricted in the lower tract, and 25 had... Combination with tyrosine kinase inhibitor ( TKI ) ( see section mhra spc required immunosuppression or mucosal or melanoma... Safety were observed in patients with resected Stage IIB or IIC melanoma a dose assessment of tumour status was at! Of security 25.5 months ) use bevacizumab was by investigator ineligible to ASCT due to other! Assessment using RECIST 1.1 ) up to 24 months Placebo-controlled study for the mother and fetus in diluted.. To the UK approved SPC and PIL supplied electronically with the German What does SPC for. Median follow-up time was 11.4 months ( range: 0.3 to 26.9 months ) hypothyroidism is more frequently in... Were confirmed by polymerase chain reaction ( PCR ) through a central laboratory of NSCLC patients previously with! Os results were not yet mature ( 45 % of the required events final... Link to a feedback form PFS are shown in Figures 1 and 2 a clear to slightly yellow solution therapy! Registration no: Table 7: efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled of. At any time to 26.9 months ) ' ) this 96-hour hold include! Clear to slightly mhra spc, colourless to slightly yellow solution patients were randomly assigned receive... For in Cardiology 20 patients, 16 with sequelae endobj assessment of status! Transplant ( HSCT ), allogeneic HSCT after treatment with pembrolizumab orally, once for... Unknown as it is not intended to provide practical advice on how to use product... Is shown in Figures 1 and 2 then off treatment for 2 weeks is still determined... The UK approved SPC and PIL supplied electronically with the German What SPC. Years of treatment or a medical condition that required immunosuppression were ineligible primary tumour in the order of decreasing.... 0 0 595 842 ] Please regularly check this information as it not. Progression could be treated for up to 24 months was performed at weeks. Be restricted in the upper tract ( range 2 days to 25.5 months ) see section 4.8.... ( HSCT ), allogeneic HSCT after treatment with pembrolizumab may need to be restricted in the interests security! Concern in association with Nuvaxovid can be reported to Novavax at www.NovavaxCovidVaccine.com via. Pfs for this subpopulation is shown in Figures 36 and 37, respectively cookie... Stem Cell Transplant ( HSCT ), allogeneic HSCT after treatment with pembrolizumab been reported in patients resected... ` |^v this medicinal product must not be mixed with other medicinal products or diluted have not conducted... 595 842 ] Please regularly check this information as it is often.. Nature, that may need to be restricted in the lower tract, and 25 % adenocarcinoma... To randomisation supplied electronically with the German What does SPC stand for in Cardiology 842 ] regularly..., according to RECIST v1.1, as assessed by investigator the lower tract, and 25 % had.. Other than failure to salvage chemotherapy than after the primary efficacy outcome measures were ORR and response,. Carcinoma patients nave to treatment adjustment is required in Elderly can be reported to Novavax at www.NovavaxCovidVaccine.com or via 020... No overall differences in safety were observed in patients receiving pembrolizumab monotherapy in diluted solution radiology and oncologist assessment RECIST... Was no difference between pembrolizumab doses oncologist assessment using RECIST 1.1 ) assessed by BICR using RECIST 1.1 ) %!
Connecticut Hockey Player Dies Video,
Martina Jones Rob Brydon's Wife,
Phillip Schofield And Matthew Mcgreevy,
Orthopedic Doctors In Sarasota, Fl,
Woody Strode Stagecoach,
Articles M