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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. /Resources 22 0 R In KEYNOTE-361, a higher number of deaths within 6 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg bw (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity. For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC regarding dosing of axitinib. Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Immune-related adverse reactions affecting more than one body system can occur simultaneously. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model, Not statistically significant after adjustment for multiplicity, Based on patients with a best objective response as confirmed complete or partial response from the final analysis, Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population), KEYNOTE-001: Open-label study in melanoma patients nave and previously treated with ipilimumab. At the time of the updated analysis, the DFS hazard ratio (95% CI) was 0.68 (0.52, 0.89) in the subgroup of patients with M0-intermediate-high risk of recurrence, 0.60 (0.33, 1.10) in the subgroup of patients with M0-high risk of recurrence, and 0.28 (0.12, 0.66) in the subgroup of patients with M1 NED. >> Reporting of suspected adverse reactions Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). 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. Name of the medicinal product 2. An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 17). /Contents 21 0 R Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion: Pembrolizumab 200 mg 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 pembrolizumab 200 mg every 3 weeks. << Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. Refer to The SPC for full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist (SABA . Results for PFS with and without censoring for new anti-cancer treatment were consistent. 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). The study demonstrated statistically significant improvements in PFS, OS, and ORR in patients randomised to pembrolizumab in combination with lenvatinib compared with sunitinib. The median time to onset of hepatitis was 3.5 months (range 8 days to 26.3 months). 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 KEYNOTE-042, a higher number of deaths within 4 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). The median survival follow-up time was 26.5 months. Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25C. 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). Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible. /Parent 3 0 R Ninety-three percent had M1 disease. A searchable list of the. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or you can search for MHRA Yellow Card in the Google Play or Apple App Store. Table 6: Efficacy results by BRAF mutation status in KEYNOTE-002, * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model. The study demonstrated a statistically significant improvement in OS and PFS for all pre-specified study populations. Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT. The baseline characteristics of these 548 patients were: median age of 51 years (range: 22 to 82), 16% age 65 or older; 59% White, 18% Asian, and 1% Black; 37% Hispanic or Latino; 56% and 43% ECOG performance status of 0 or 1, respectively; 63% received bevacizumab as study treatment; 21% with adenocarcinoma and 5% with adenosquamous histology; for patients with persistent or recurrent disease with or without distant metastases, 39% had received prior chemoradiation only and 17% had received prior chemoradiation plus surgery. *Adverse reaction frequencies presented in Table 2 may not be fully attributable to pembrolizumab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. Patients were enrolled regardless of tumour PD-L1 expression status. Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2. Updated efficacy results with a median follow-up time of 45.5 months are summarised in Table 11 and Figures 6 and 7. At the pre-specified interim analysis, for the IMDC risk category, the OS hazard ratio (HR) for patients randomised to the pembrolizumab combination arm compared with sunitinib in the favourable risk group was 0.64 (95% CI 0.24, 1.68), for the intermediate risk group the OS HR was 0.53 (95% CI 0.35, 0.82), and for the poor risk group the OS HR was 0.43 (95% CI 0.23, 0.81). No dose adjustment is required in elderly individuals 65 years of age. KEYTRUDA is for intravenous use. 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. 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. Hypothyroidism occurred in 939 (12.3%) patients, including Grade 2 or 3 cases in 687 (9.0%) and 8 (0.1%) patients, respectively, receiving pembrolizumab. Chemical and physical in-use stability has been demonstrated for 6 hours at 2C to 25C from the time of first needle puncture to administration. Results of KEYNOTE-361 for pembrolizumab in combination with chemotherapy did not show statistically significant improvement in PFS as assessed by BICR using RECIST 1.1 (HR 0.78; 95% CI: 0.65, 0.93; p=0.0033), and OS (HR 0.86; 95% CI: 0.72, 1.02; p=0.0407) versus chemotherapy alone. This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. No dose adjustment is needed for patients with mild or moderate renal impairment. It is used by healthcare professionals, such as doctors, nurses and pharmacists. . One-sided 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). The efficacy of pembrolizumab was investigated in KEYNOTE-204, a randomised, open-label, active-controlled study conducted in 304 patients with relapsed or refractory cHL. Key eligibility criteria were locally recurrent unresectable or metastatic TNBC, regardless of tumour PD-L1 expression, not previously treated with chemotherapy in the advanced setting. Dont include personal or financial information like your National Insurance number or credit card details. Secondary outcome measures were ORR and response duration. 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). Colitis occurred in 158 (2.1%) patients, including Grade 2, 3 or 4 cases in 49 (0.6%), 82 (1.1%) and 6 (0.1%) patients, respectively, receiving pembrolizumab. The median follow-up time was 17.2 months (range: 0.3 to 29.4 months). A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. When reporting, please include the vaccine brand and batch/lot number, if available. endobj This is based on the Summary of Product Characteristics of the product. . Table 13: Efficacy results (PD-L1 TPS 50%) in KEYNOTE-042, Figure 10: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-042 (patients with PD-L1 expression TPS 50%, intent to treat population). Patients were randomised (1:1) to one of the two treatment groups: Treatment Group 1: Pembrolizumab 200 mg plus chemotherapy with or without bevacizumab, Treatment Group 2: Placebo plus chemotherapy with or without bevacizumab. Clinical particulars 5. Table 38: Efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in oesophageal carcinoma patients nave to treatment. Immune-related adverse reactions (see section 4.4). At the pre-specified interim analysis of ORR (median follow-up time of 12.8 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus axitinib with sunitinib p-Value < 0.0001. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). Description of selected adverse reactions. The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination (see section 5.1). Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. >> Secondary efficacy outcome measures were duration of response, PFS and OS. [j We use some essential cookies to make this website work. Assessment of tumour status was performed every 9 weeks. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Nominal two-sided p-Value based on the stratified Cochran-Mantel-Haenszel (CMH) test. Secondary efficacy outcome measures included response duration, PFS, and OS. Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. /MediaBox [0 0 595 842] Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. SPC Flooring. Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss. Pembrolizumab 2 mg/kg bw every 3 weeks in patients previously treated with ipilimumab, Pembrolizumab 2 mg/kg bw every 3 weeks in patients nave to treatment with ipilimumab, * Includes patients without measurable disease at baseline by independent radiology, /Type /Page The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL or patients aged 12 years and older with melanoma is 2 mg/kg bodyweight (bw) (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. The median time to onset of nephritis was 4.2 months (range 12 days to 21.4 months). For Grades 3 or 4 infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2). Individuals may not be fully protected until 7 days after their second dose. 11 0 obj /Contents 27 0 R The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status 2. Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. 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). Safety and immunogenicity of COVID-19 vaccines given as a third dose (booster) following completion of a primary vaccination series with another authorizsed COVID-19 vaccine in the UK. 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. Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS 50% based on the PD-L1 IHC 22C3 pharmDxTM Kit. The efficacy, safety, and immunogenicity of the vaccine has been assessed in a limited number of immunocompromised individuals. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. /CropBox [0 0 595 842] Table 23 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients. Lenvatinib should be withheld, dose reduced, or discontinued in accordance with the instructions in the lenvatinib SmPC for combination with pembrolizumab. 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. Table 23: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052, Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens. 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. Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Medicines and Healthcare products Regulatory Agency, Drugs and pharmaceutical electronic market information tool (eMIT), Parallel import licences: lists of approved products, Immunomodulatory drugs: temporary pregnancy prevention guidance during coronavirus (COVID-19), Marketing authorisations: lists of granted licences, Clinical trials for medicines: authorisation assessment performance, the leaflets which are provided with medicines, the description of the medicinal products properties and how it can be used, scientific reports about marketing authorisations for medicines. >> Colitis has been reported in patients receiving pembrolizumab (see section 4.8). 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), In patients with ALT 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. Among the 83 patients with endometrial cancer, the baseline characteristics were: median age of 64 years (range: 42 to 86), 46% age 65 or older; 84% White, 6% Asian, and 4% Black; and ECOG PS 0 (46%) and 1 (54%). Animal fertility studies have not been conducted with pembrolizumab. The clinical significance of this is unknown. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. >> Enrolment was completed in November 2020. Severe infusion-related reactions, including hypersensitivity and anaphylaxis, have been reported in patients receiving pembrolizumab (see section 4.8). 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 . For full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist ( SABA 2C to 25C the... Beyond progression if the patient was clinically stable patients with initial evidence of lymph node were... Discontinuation of pembrolizumab in 48 ( 0.6 % ) patients demonstrated a statistically significant improvement OS. These results reflect enrolment that occurred during the time of 45.5 months are summarised in Table 11 Figures... Management Guidelines signs or symptoms of adverse reactions, infusion should be stopped pembrolizumab. 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Nephritis was 4.2 months ( range: 0.3 to 29.4 months ) be stable up 12... Summarises key efficacy measures for the entire intent to treat ( ITT ) population ( range: 0.3 29.4., have been reported in patients receiving pembrolizumab ( see section 4.2 ) 9 weeks be withheld dose!, have been reported in patients receiving pembrolizumab mhra spc see section 4.8 ) ) patients Guidelines!
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