The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). 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. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. Assessment of tumour status was performed every 9 weeks. The Kaplan-Meier curve for OS for the TPS 50% population based on the final analysis is shown in Figure 10. 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). Participants may have received up to 2 platinum-containing therapies in total, as long as one was given in the neoadjuvant or adjuvant treatment setting. KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. This product is considered high in sodium. Well send you a link to a feedback form. Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC. In patients with EC, Grades 3-5 adverse reactions were 89% for pembrolizumab in combination with lenvatinib and 73% for chemotherapy alone. Nuvaxovid was assessed in individuals 18 years of age and older. 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. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Table 41 summarises key efficacy measures and Figures 34 and 35 show the Kaplan-Meier curves for PFS and OS based on the final analysis with a median follow-up time of 20.2 months (range: 0.3 to 53.1 months) for patients with tumour PD-L1 expression CPS 10. Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression. For precautions to be taken before administering the vaccine, see section 4.4. Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. The cHL population (n=22) included patients 11 to 17 years of age. Nominal p-Value based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region. Hyperthyroidism led to discontinuation of pembrolizumab in 4 (0.1%) patients. SHCP APC . Hi, As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. Remind patients to check and remove the mouthpiece cover properly before inhaling a dose . The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, placebo-controlled, observer-blinded clinical study (Study 2019nCoV-101, Part 2) conducted in participants aged 18 to 84years of age. tenosynovitis (tendonitis, synovitis and tendon pain), ff. No dose reductions of KEYTRUDA are recommended. 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. In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hyperthyroidism was 10.9%, the majority of which were Grade 1 or 2. See Table 25 and Figures 18 and 19. All 827 of these patients received prior systemic therapy for EC: 69% had one, 28% had two, and 3% had three or more prior systemic therapies. Dont worry we wont send you spam or share your email address with anyone. The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor. The primary efficacy outcome measures were OS and PFS as assessed by BICR using RECIST 1.1. Table 13 summarises key efficacy measures for the TPS 50% population at the final analysis performed at a median follow-up of 15.4 months. Ninety percent of patients were treatment nave, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. For Grade 4 haematological toxicity, only in patients with cHL, KEYTRUDA should be withheld until adverse reactions recover to Grades 0-1. endobj A subset of 104 participants received a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series. The patient may also choose to report any adverse drug reaction direct to the MHRA on a Yellow Card , available at pharmacies, GP surgeries or from the Yellow Card hotline (freephone 0808 100 3352 during business hours). The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. 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 20: Kaplan-Meier curve for overall survival for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Table 27: Efficacy results for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg bw every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg bw every 3 weeks (n=278). Table 8 summarises efficacy results by PD-L1 expression. >> The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Disease characteristics were squamous (21%) and non-squamous (70%); stage IIIA (2%); stage IIIB (7%); stage IV (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%). The Novavax COVID-19 Vaccine, Adjuvanted demonstrated a booster response regardless of the vaccine used for primary vaccination. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). 11 0 obj Response was assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at Week 12. KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with: - advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation; - unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Colitis has been reported in patients receiving pembrolizumab (see section 4.8). Use of pembrolizumab for first-line treatment of patients with HNSCC. Eighty-eight percent had M1 disease and 12% had M0 disease. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Hypothyroidism led to discontinuation of pembrolizumab in 6 (0.1%) patients. 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. 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). /Contents 17 0 R Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. EFS was defined as the time from randomisation to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, second primary malignancy, or death due to any cause. Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP. Pembrolizumab was continued for a maximum of 24 months; however, treatment with lenvatinib could be continued beyond 24 months. >> 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, Such treatment Secondary efficacy outcome measures were duration of response, PFS, and OS. If you use assistive technology (such as a screen reader) and need a A total of 976 patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (or the paediatric [12 to 17 years old] dose of 2 mg/kg intravenously [up to a maximum of 200 mg] every three weeks) (n=487) or placebo (n=489), for up to one year or until disease recurrence or unacceptable toxicity. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). Represents (n1, n2) populations defined as: n1 = number of participants in adult main study (18 through 25 years) with non-missing neutralizing antibodies result Name of the medicinal product 2. endobj See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. 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. The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). Table 29: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 expression in KEYNOTE-048 (CPS 1 to < 20), Based on the stratified Cox proportional hazard model, Response: Best objective response as confirmed complete response or partial response, KEYNOTE-040: Controlled study in HNSCC patients previously treated with platinum-containing chemotherapy. When reporting, please include the vaccine brand and batch/lot number, if available. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Pneumonitis resolved in 190 patients, 6 with sequelae. Forty-one percent of patients received 2 or more prior lines of therapy. Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8). The median duration was 1.1 month (range 1 day to 45.2 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. Pack sizes of 10, 20, 30, 40, 60 or 90 capsules. /Rotate 0 Each mL of concentrate contains 25 mg of pembrolizumab. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. >> /Producer (Acrobat Distiller 7.0.5 \(Windows\)) EIR SPC Flooring ZXE2002. 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. In the event of an overdose, monitoring of vital functions and possible symptomatic treatment is recommended. Data were available for 95 of the 106 endpoint cases (90%). 13 0 obj /PageLabels 4 0 R The median time to onset of hypothyroidism was 3.4 months (range 1 day to 25.9 months). Microsoft Word - 1646658070014998238_spc-doc.doc Patients received pembrolizumab 200 mg every 3 weeks (n=210; KEYNOTE-087) or 10 mg/kg bw every 2 weeks (n=31; KEYNOTE-013) until unacceptable toxicity or documented disease progression. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Based on the stratified Cox proportional hazard model, As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. Upon enrolment in the adult main study, participants were stratified by age (18 to 64 years and 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. The baseline characteristics of these 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours. 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. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 28 years (range: 18 to 84 years); 40% were female; 91% were Black/African American; 2% were White; 3% were multiple races, 1% were Asian; and 2% were Hispanic or Latino; and 5.5% were HIV-positive. /MediaBox [0 0 595 842] 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. 09 / 22. The median duration was not reached (range 3 days to 40.1+ months). Table 33: Efficacy results in KEYNOTE-581. Based on stratified log-rank test (compared to an alpha boundary of 0.00549), In order to avoid intraneural injection and to prevent nerve injuries in connection with stream Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. KEYTRUDA is for single use only. Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Based on stratified log-rank test (compared to an alpha boundary of 0.00144), 3 0 obj Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. . 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. Date of first authorisation: 1 January 2021. Report a side effect with a medicine or medical device. Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. The most frequent solicited adverse reactions were injection site tenderness (81%), fatigue (63%), injection site pain (55%), muscle pain (51%), malaise (47%) and headache (46%), joint pain (29%), and fever (17%) with a median duration of 1 to 3days following vaccination. Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. SHCP APC . Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered. 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. A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in 1% of tumour and tumour-associated immune cells relative to all viable tumour cells MEL score) vs. PD-L1 negative. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate 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 primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Neutralising antibody responses were compared with those observed in seronegative/PCR-negative adult participants aged 18 through 25 years from the adult main study (Per Protocol Immunogenicity ( PP-IMM) Analysis Set) as shown in Table 3. Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. In these patient populations, the most frequent adverse reactions were diarrhoea (58%), hypertension (54%), hypothyroidism (46%), fatigue (41%), decreased appetite (40%), nausea (40%), arthralgia (30%), vomiting (28%), weight decreased (28%), dysphonia (28%), abdominal pain (28%), proteinuria (27%), palmar-plantar erythrodysaesthesia syndrome (26%), rash (26%), stomatitis (25%), constipation (25%), musculoskeletal pain (23%), headache (23%) and cough (21%). Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract. )spc( . )sdi( Tumour response was assessed at 12-week intervals. search for MHRA Yellow Card in the Google Play or Apple App Store. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, 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. Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. either cisplatin or carboplatin with gemcitabine) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. Response: Best objective response as confirmed complete response or partial response, Figure 38: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1), * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin) with or without bevacizumab, Figure 39: Kaplan-Meier curve for progression free survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1). /Rotate 0 Patients should be monitored for suspected severe skin reactions and other causes should be excluded. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. The median area under the concentration time curve at steady-state over 3 weeks (AUC0-3weeks) was 794 mcgday/mL at a dose of 2 mg/kg bw every 3 weeks and 1,053 mcgday/mL at a dose of 200 mg every 3 weeks. V3.0 except where otherwise stated, if available in RCC any unused medicinal product must be. 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Outcome measure was ORR as assessed by BICR using RECIST 1.1 brand and number... > > /Producer ( Acrobat Distiller 7.0.5 \ ( Windows\ ) ) EIR SPC Flooring ZXE2002 product or material! ) ( see section 4.8 ) 40, 60 or 90 capsules targeted therapy before receiving.! Section 4.2 ) tumour response was assessed at 12-week intervals % were refractory to frontline chemotherapy and ~ 45 had! % received prior ASCT no difference between pembrolizumab doses booster response regardless of the vaccine brand batch/lot! ( TKI ) ( see section 4.4 Open Government Licence v3.0 except where otherwise.. For intramuscular injection only, preferably into the deltoid muscle of the 106 endpoint cases ( 90 % )..
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