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%). Among the study population (355 patients in the pembrolizumab with lenvatinib arm and 357 in the sunitinib arm), the baseline characteristics were: median age of 62 years (range: 29 to 88 years), 41% age 65 or older; 74% male; 75% White, 21% Asian, 1% Black, and 2% other races; 17% and 83% of patients had a baseline KPS of 70 to 80 and 90 to 100, respectively; patient distribution by IMDC risk categories was 33% favourable, 56% intermediate and 10% poor, and by MSKCC prognostic groups was 27% favourable, 64% intermediate and 9% poor. The median duration was not reached (range 3 days to 40.1+ months). Paclitaxel 175 mg/m2 + carboplatin AUC 5 mg/mL/min, 4. *. There is limited experience with use of Nuvaxovid in pregnant women. SHCP APC . 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 section 4.8). However, comparatively low doses . Date of first authorisation: 1 January 2021. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate Sodium lauryl sulphate Maize starch Calcium hydrogen phosphate dihydrate Magnesium stearate 6.2 Incompatibilities Not applicable 6.3 Shelf life 36 months 6.4 Special precautions for storage Do not store above 25C. 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. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). Discard the vial if visible particles are observed. 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. ?F}
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Dma;}@zqZ+/RwHrGr&iy3gMdyuDT@S0:n@BsRssHsVBT{{V!B KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Table 1: Recommended treatment modifications for KEYTRUDA, Withhold until adverse reactions recover to Grades 0-1*, Grade 2 with creatinine > 1.5 to 3 times upper limit of normal (ULN), Grade 2 adrenal insufficiency and hypophysitis, Withhold treatment until controlled by hormone replacement, Grades 3 or 4 adrenal insufficiency or symptomatic hypophysitis, Type 1 diabetes associated with Grade 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis. Patients treated with pembrolizumab without disease progression could be treated for up to 24 months. Of the 540 patients, 61% were male, 43% were 65 years (median age was 62 years [range 15-89]) and 98% were white. You can change your cookie settings at any time. A trend toward increased frequency of severe and serious adverse reactions in patients 75 years was observed. EIR Vinyl Flooring ZXE2001. If you are unable to complete your LogIn successfully please contact the Adverse Incident Centre for assistance and advice: sabre@mhra.gov.uk or 020 3080 7336. The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, observer-blinded, placebo-controlled clinical study administered as a single booster dose (Study 2019nCoV-101, Part 2) in healthy adult participants aged 18 to 84years of age who were seronegative to SARS-CoV-2 at baseline. 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. Currently available data are described in sections 4.8, 5.1 and 5.2. endobj It will take only 2 minutes to fill in. A searchable list of the. Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anti-cancer agents. Qualitative and quantitative composition 3. The most common tumour types by histology were Hodgkin lymphoma (13.7%), glioblastoma multiforme (9.3%), neuroblastoma (6.2%), osteosarcoma (6.2%) and melanoma (5.6%). Such treatment The ORR difference (95% CI) for the favourable, intermediate and poor risk groups were 17.0% (5.3, 28.4), 25.5% (16.7, 33.9), and 31.5% (15.7, 46.2), respectively. Qualitative and quantitative composition 3. One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5.1). For instructions on dilution of the medicinal product before administration, see section 6.6. Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. << Pharmaceutical form 4. 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. From a microbiological point of view, the product, once diluted, should be used immediately. If ALT or AST 10 times ULN or > 3 times ULN with concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. The study excluded patients with endometrial sarcoma, carcinosarcoma, pre-existing Grade 3 fistula, uncontrolled BP (> 150/90 mmHg), significant cardiovascular impairment or event within previous 12 months, or patients who had active autoimmune disease or a medical condition that required immunosuppression. Assessment of tumour status was performed at Week 9 and then every 9 weeks for the first year, followed by every 12 weeks thereafter. /Rotate 0 << Well send you a link to a feedback form. Individual response values recorded as below the LLOQ were set to half LLOQ. 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. As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90). Get the top SPC abbreviation related to Cardiology. Patients were randomised (1:1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks up to 24 months in combination with lenvatinib 20 mg orally once daily. Special populations Elderly No dose adjustment is required in elderly. It will take only 2 minutes to fill in. 4.6 Fertility, Pregnancy and lactation Pregnancy Data on a limited number (242) of exposed pregnancies indicate no adverse effects of Indocyanine green on pregnancy or on the health of the 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. Cisplatin could be administered on Day 2 of each 3-week treatment cycle. tenosynovitis (tendonitis, synovitis and tendon pain), ff. 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,
Eighty-five percent of patients had visceral metastases, including 21% with liver metastases. The median duration of the post-progression therapy was 2.8 months. There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS. The efficacy of pembrolizumab in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was investigated in KEYNOTE-826, a multicentre, randomised, double-blind, placebo-controlled study that enrolled 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitising agent. Table 36: Efficacy results in KEYNOTE-177. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Colitis resolved in 130 patients, 2 with sequelae. Updated RFS results at a median follow-up of 26.9 months were consistent with the final analysis for RFS for patients randomised to the pembrolizumab arm compared with placebo (HR 0.64; 95% CI 0.50, 0.84). 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. There were no Grade 5 hepatic events. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment. Table 20: Efficacy results in KEYNOTE-087 and KEYNOTE-013,
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. The Public Assessment Report will be published shortly. The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. 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. Most immune-related adverse reactions occurring during treatment with pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care. For suspected SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. Non-clinical data reveal no special hazard for humans based on conventional studies of repeat-dose toxicity, local tolerance, genotoxicity, and reproductive and developmental toxicity. 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. All study treatments were administered on Day 1 of each 3-week treatment cycle. In preclinical murine models, PD-1 plus TKI inhibitors have demonstrated enhanced anti-tumour activity compared to either agent alone. Secondary efficacy outcome measures were ORR and response duration. Head and neck squamous cell carcinoma (HNSCC). Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Immune-related severe skin reactions occurred in 130 (1.7%) patients, including Grade 2, 3, 4 or 5 cases in 11 (0.1%), 103 (1.3%), 1 (< 0.1%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. Study1 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo-controlled study with an adult main study conducted in participants 18years of age and older in United States and Mexico, and a paediatric expansion occurring in participants 12 through 17 years of age in the United States. o Followed by four additional cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 5-8 of treatment regimen in combination with: Doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen and, Cyclophosphamide 600 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen. 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%). 09/24. Hyperthyroidism may be managed symptomatically. The median follow-up time was 17.2 months (range: 0.3 to 29.4 months). The study demonstrated statistically significant improvements in PFS, OS, and ORR in patients randomised to pembrolizumab in combination with lenvatinib compared with sunitinib. Patients were enrolled regardless of tumour PD-L1 expression status. Table 15: Efficacy results by PD-L1 expression in KEYNOTE-189
/Author () 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. KEYTRUDA must not be administered as an intravenous push or bolus injection. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. The baseline characteristics of these patients were: median age of 65 years (range: 30 to 86), 50% age 65 or older; 61% White, 21% Asian, and 4% Black; ECOG PS of 0 (59%) or 1 (41%), and 84% with pMMR tumour status and 16% with dMMR tumour status. Participants will be followed for up to 24 months after the second dose for assessments of safety, and efficacy against COVID-19. 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. Results for PFS with and without censoring for new anti-cancer treatment were consistent. British National Formulary accessed online sept 2019 3. Extension (Km 2 ) 141. 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. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2C to 8C. A total of 147 symptomatic mild, moderate, or severe COVID-19 cases among all adult participants, seronegative (to SARS-CoV-2) at baseline, were accrued for the complete analysis (PP-EFF Analysis Set) of the primary efficacy endpoint, with 51 (3.62%) cases for Nuvaxovid versus 96 (7.05%) cases for placebo. >> 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). No dose reductions are recommended for KEYTRUDA. * With additional 12 months of follow-up after the pre-specified final analysis for PFS. Pembrolizumab in combination with chemotherapy should be used with caution in patients 75 years after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). Table 9 summarises efficacy results by PD-L1 expression. Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively. The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). 6 0 obj KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1). Co-administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. 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). /Length 6 0 R 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). BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). Two patients experienced hepatic VOD, one of which was fatal. Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually. In patients with CRC treated with pembrolizumab as monotherapy (n=153), the incidence of colitis was 6.5% (all Grades) with 2.0% Grade 3 and 1.3% Grade 4. In patients with cHL (n=389) the incidence of hypothyroidism was 17%, all of which were Grade 1 or 2. Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy. H0: difference in % = 0 versus H1: difference in % > 0. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. No dose adjustment is needed for patients with mild or moderate hepatic impairment. * If treatment-related toxicity does not resolve to Grades 0-1 within 12 weeks after last dose of KEYTRUDA, or if corticosteroid dosing cannot be reduced to 10 mg prednisone or equivalent per day within 12 weeks, KEYTRUDA should be permanently discontinued. >> New information on this medicinal product will be reviewed at least every year and this SmPC will be updated as necessary. Do not administer the vaccine if either are present.
Microsoft Word - 1646658070014998238_spc-doc.doc 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. The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1). The median duration was 1.1 month (range 1 day to 45.2 months). Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. Liver enzymes should be monitored before initiation of and periodically throughout treatment. 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. 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Pembrolizumab were reversible and managed with interruptions of pembrolizumab, administration of corticosteroids and/or supportive care line.... Immediately, chemical and physical in-use stability of keytruda has been demonstrated 96. To understand how you use GOV.UK, remember your settings and improve government services a to. In this patient population of view, the product, once diluted, should be followed see! Of individual subgroups of causality, PD-1 plus TKI inhibitors have demonstrated enhanced anti-tumour activity compared to either alone! Who were refractory to first line therapy during treatment with pembrolizumab and at! Duration following pembrolizumab discontinuation at cycle 35 resulted in no change to influenza vaccine immune responses measured. To 45.2 months ) in this patient population set additional cookies to understand how you GOV.UK... 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