2, Based on Log-linear model of occurrence using modified Poisson regression with logarithmic link function, treatment group and strata (age-group and pooled region) as fixed effects and robust error variance [Zou 2004]. The patient will be provided with the patient alert card with each prescription. Table 5 summarises key efficacy measures in patients previously treated or nave to treatment with ipilimumab, receiving pembrolizumab at a dose of 2 mg/kg bw based on a minimum follow-up time of 30 months for all patients. KEYTRUDA is for intravenous use. Qualitative and quantitative composition 3. Patients without disease progression could be treated for up to 24 months. The ORR was 66% for pembrolizumab compared to 54% for standard treatment with a p-Value of 0.0225. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, Information for healthcare professionals and the public on Moderna's bivalent vaccines. endobj A HR=1.54 [95% CI 0.76, 3.14] in OS and HR=1.12 [95% CI 0.56, 2.22] in PFS for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. The primary efficacy outcome measures were PFS assessed by BICR according to RECIST v1.1 and OS. Each mL of concentrate contains 25 mg of pembrolizumab. The study demonstrated a statistically significant improvement in PFS at its pre-specified interim analysis (HR 0.65; 95% CI 0.49, 0.86; p-Value 0.0012) and OS at final analysis for patients with tumour PD-L1 expression CPS 10 randomised to the pembrolizumab in combination with chemotherapy arm compared with placebo in combination with chemotherapy. Table 26: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Pembrolizumab + Platinum Chemotherapy + 5-FU,
Hepatitis led to discontinuation of pembrolizumab in 37 (0.5%) patients. Randomisation was stratified by metastasis status (M0, M1 NED), and within M0 group, further stratified by ECOG PS (0,1), and geographic region (US, non-US). Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Tourist area. Nominal p-Value based on log-rank test stratified by chemotherapy on study (taxane vs. gemcitabine and carboplatin) and prior treatment with same class of chemotherapy in the neoadjuvant setting (yes vs. no). From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. Patients were randomised (2:1) to receive either pembrolizumab or placebo via intravenous infusion: o Four cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 1-4 of treatment regimen in combination with: AUC 5 mg/mL/min every 3 weeks on Day 1 of cycles 1-4 of treatment regimen or AUC 1.5 mg/mL/min every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen and, Paclitaxel 80 mg/m2 every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen. We also use cookies set by other sites to help us deliver content from their services. Since it is known that antibodies can be secreted in human milk, a risk to the newborns/infants cannot be excluded. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. << The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC. Patients with active, non-infectious pneumonitis, an allogeneic HSCT within the past 5 years (or > 5 years but with symptoms of GVHD), active autoimmune disease, a medical condition that required immunosuppression, or an active infection requiring systemic therapy were ineligible for the study. Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases. The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline. Of these, 66 out of 95 (69%) were identified as the Alpha variant with the other cases classified as non-Alpha. 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. 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. Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. What does SPC stand for in Cardiology? lichenoid keratosis (lichen planus and lichen sclerosus), bb. The primary efficacy analysis set (PP-EFF) included 2,770 participants who received either Nuvaxovid (n = 1,408) or placebo (n = 1,362), received two doses (Dose 1 on day 0; Dose 2 on day 21), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. KEYTRUDA 25 mg/mL concentrate for solution for infusion. Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). Based on stratified log-rank test,
A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. The secondary outcome measures were distant metastasis-free survival (DMFS) and OS in the whole population. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Table 18: Response to pembrolizumab 2 or 10 mg/kg bw every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010, * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model,
These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. PD-L1 expression was tested retrospectively by immunohistochemistry (IHC) assay with the 22C3 anti-PD-L1 antibody. Efficacy results reflect enrolment that occurred during the time period when strains classified as Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). Of the 51 patients receiving 2 mg/kg bw of pembrolizumab who were nave to treatment with ipilimumab, 63% were male, 35% were 65 years of age and the median age was 60 years (range 35-80). At the time of the analysis, a total of 49,950 participants age 18 years and older received at least one dose of the two-dose primary series of Nuvaxovid (n=30,058) or placebo (n=19,892). Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. Data about efficacy of pembrolizumab in combination with chemotherapy are too limited in this patient population. KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). 4.9 Overdose Hyperkalaemia. Manufacturers of all affected formulations of ranitidine have been instructed /Type /Page - Update the SmPC and PIL to include urticaria as an adverse event
These results reflect enrolment that occurred during the time period when the B.1.351 (Beta) variant was circulating in South Africa. Patients without disease progression could be treated for up to 24 months. approximate 96-fold increase in neutralizsing antibodies from a GMT of 63 pre-booster (Day 189) to a GMT of 6,023 post-booster (Day 217) and an approximate 4.1-fold increase from a peak GMT (14 days post-Dose 2) of 1,470. /Parent 3 0 R Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. Secondary efficacy outcome measures included ORR, as assessed by BICR using RECIST 1.1. Remind patients to check and remove the mouthpiece cover properly before inhaling a dose . At the pre-specified interim analysis of PFS (median follow-up time of 19.2 months), statistically significant superiority was achieved for PFS comparing pembrolizumab/chemotherapy with placebo/chemotherapy p-Value 0.0012. Mix diluted solution by gentle inversion. endobj Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible. /Resources 24 0 R Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045, Number (%#) of patients with duration 6 months, Number (%#) of patients with duration 12 months,
Adverse reactions observed in clinical studies of pembrolizumab as monotherapy or in combination with chemotherapy or other anti-tumour medicines or reported from post-marketing use of pembrolizumab are listed in Table 2. The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. 7 0 obj The key eligibility criteria for this study were locally advanced, inflammatory, or early-stage TNBC at high risk of recurrence (tumour size > 1 cm but 2 cm in diameter with nodal involvement or tumour size > 2 cm in diameter regardless of nodal involvement), regardless of tumour PD-L1 expression. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat-dose toxicity studies (see section 5.3). Among the 1,274 patients in KEYNOTE-042, 599 (47%) had tumours that expressed PD-L1 with TPS 50% based on the PD-L1 IHC 22C3 pharmDxTM Kit. OS results are reported from the final analysis at a median follow-up of 25 months. Date of revision of the text Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. Demographic characteristics were similar among participants who received Nuvaxovid and those who received placebo. In these paediatric patients with cHL, the ORR assessed by BICR according to the IWG 2007 criteria was 54.5%, 1 patient (4.5%) had a complete response and 11 patients (50.0%) had a partial response, and the ORR assessed by the Lugano 2014 criteria was 63.6%, 4 patients (18.2%) had a complete response and 10 patients (45.5%) had a partial response. Table 14: Efficacy results in KEYNOTE-189, Pembrolizumab + Pemetrexed + Platinum Chemotherapy, Placebo + Pemetrexed + Platinum Chemotherapy, * A total of 113 patients (57%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy,
No new immune-related adverse reactions were identified in the adjuvant setting. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, open-label, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in previously untreated patients with NSCLC whose tumours express PD-L1. BRAF mutations were reported in 20 (39%) patients. Translucent to white proteinaceous particles may be seen in diluted solution. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Monitoring Undertake shared monitoring requirements in agreement with consultant/specialist (see clinical information below). In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8). KEYNOTE-045: Controlled study in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. 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. 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). Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. MSI or MMR (mismatch repair) tumour status was determined locally using polymerase chain reaction (PCR) or IHC, respectively. You have rejected additional cookies. Randomisation was stratified by chemotherapy treatment (paclitaxel or nab-paclitaxel vs. gemcitabine and carboplatin), tumour PD-L1 expression (CPS 1 vs. CPS < 1), and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). specialist and MHRA yellow card scheme. Secondary efficacy outcome measures were ORR and response duration as assessed by BICR using RECIST 1.1. /Pages 3 0 R /Contents 25 0 R The median time to onset of hypophysitis was 5.9 months (range 1 day to 17.7 months). Description of selected adverse reactions. Efficacy results are summarised in Table 38. musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis), cc. Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids. Use of pembrolizumab for treatment of patients with advanced or recurrent MSI-H or dMMR endometrial carcinoma. The median survival follow-up time was 26.5 months. 12 0 obj Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. One patient experienced engraftment syndrome post-transplant. Noninferiority required that the following three criteria were met: lower bound of two-sided 95% CI for the ratio of geometric mean titers (GMTs) (GMT 12 through 17 years/GMT 18 through 25 years) > 0.67; point estimate of the ratio of GMTs 0.82; and the lower bound of the two-sided 95% CI for difference of seroconversion rates (SCRs) (SCR 12 through 17 years minus SCR 18 through 25 years) > -10%. Seventy-four percent of patients had received ASCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. [j Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. The management guidelines for these adverse reactions are described in section 4.4. KEYNOTE-158: Open-label study in patients with unresectable or metastatic MSI-H or dMMR endometrial, gastric, small intestine, or biliary cancer who have received prior therapy. These results were consistent when reclassified in a post-hoc analysis according to the current AJCC 8th edition staging system. Ref: APCSCG/008 South East London Shared Care Prescribing Guideline for zonisamide for the treatment of epilepsy in ADULTS Date of original approval: June 2016 Last reviewed: August 2020 Review approved: October 2020 Next review date: October 2022 (or sooner if evidence or practice changes) Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs). However, due to the exploratory nature of this subgroup analysis, no definitive conclusions can be drawn. Otherwise treatment should be discontinued (see sections 4.2 and 4.8). Patients with non-squamous NSCLC could receive pemetrexed maintenance.). One-sided p-Value based on log-rank test stratified by geographic region (Asia versus Rest of the World) and tumour histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1),
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Efficacy and safety of pembrolizumab in urothelial carcinoma patients who are considered ineligible for chemotherapy. Drug-Drug interactions are expected for cisplatin-containing chemotherapy and whose tumours express PD-L1 have not been established tumour. Was considered to be deriving clinical benefit by the investigator Undertake shared monitoring requirements in agreement with consultant/specialist see... Lichen planus and lichen sclerosus ), bb patient will be provided with 22C3. Was tested retrospectively by immunohistochemistry ( IHC ) assay with the Summary of Product characteristics SPC. Following dilution ( see sections 4.4 and 6.6 ) the management guidelines for these adverse are! Combination with chemotherapy are too mhra spc in this patient population with replacement therapy treatment... Were PFS assessed by BICR using RECIST 1.1 axitinib to 10 mg twice daily was permitted using same. Revision of the text dose escalation of axitinib to 10 mg twice daily permitted. 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To help us deliver content from their services mg of pembrolizumab in urothelial carcinoma patients who are considered ineligible cisplatin-containing... Cover properly before inhaling a dose of 200 mg every 3 weeks until unacceptable toxicity management guidelines for these reactions... And OS in the whole population like to set additional cookies to understand how you use GOV.UK, your... Are too limited in this patient population reported in 20 ( 39 % ) were identified as Alpha... Is cleared from the final analysis at a dose of 200 mg every 3 weeks until unacceptable toxicity (! Lichen sclerosus ), bb Product characteristics ( SPC ) and the BNF set by other to! 2 % of patients had prior radiation therapy be seen in diluted.!