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. For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC regarding dosing of axitinib. 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). Dont include personal or financial information like your National Insurance number or credit card details. Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable. In clinical studies in patients treated with pembrolizumab 2 mg/kg bw every three weeks, 200 mg every three weeks, or 10 mg/kg bw every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. 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. Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months). The median interval between the second and the third doses was 165 days. stream This medicinal product has been authorised under a so-called conditional approval scheme. 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. Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. 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. cBR&0q(0a&0ej"lL |6OD+7F!`[,CyfcqZLIWll>T"1IMvfG|XmpE?$I-^W} The median duration was 3.6 months (range 3 days to 48.1+ months). Secondary efficacy outcome measures were ORR and duration of response, according to RECIST 1.1 as assessed by the investigator. 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. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. Patients should be monitored for signs and symptoms of colitis, and other causes excluded. << /ModDate (D:20190624094123+01'00') It is important that precautions are in place to avoid injury from fainting. Participants with confirmed infection or prior infection due to SARSCoV-2 at the time of randomisation were not included in the primary efficacy analysis. /CropBox [0 0 595 842] All participants were offered the opportunity to continue to be followed in the study. 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 key secondary outcome measure was OS. stream 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). /Subtype /XML A partnership between NHS organisations in South East London: Bexley, Bromley, Greenwich, Lambeth, Lewisham and Southwark Clinical Commissioning Groups (CCGs) and GSTFT/KCH /SLAM/ Oxleas NHS Foundation Trusts/Lewisham & Greenwich NHS Trust Table 17: Efficacy results by PD-L1 expression in KEYNOTE-407 All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. Do not co-administer other medicinal products through the same infusion line. OS results are reported from the final analysis at a median follow-up of 25 months. Animal fertility studies have not been conducted with pembrolizumab. # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. /Contents 15 0 R 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). Randomisation was stratified by risk categories (favourable versus intermediate versus poor) and geographic region (North America versus Western Europe versus Rest of the World). When suggestions are available use up and down arrows to review and ENTER to select. The M1 NED category included patients with metastatic disease who had undergone complete resection of primary and metastatic lesions. Some information may have been excluded from public view. It is unknown whether pembrolizumab is secreted in human milk. Translucent to white proteinaceous particles may be seen in diluted solution. 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. Efficacy in Adolescents 12 through 17 years of age. 3. * The primary analysis of PFS included censoring for new anti-cancer treatment. In KEYNOTE-051, 161 paediatric patients (62 children aged 9 months to less than 12 years and 99 adolescents aged 12 years to 17 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg bw every 3 weeks. In the Hodgkin lymphoma population (n=22), in patients aged 11 years to 17 years, the baseline characteristics were median age 15 years; 64% male; 68% White; 77% had a Lansky/Karnofsky scale 90-100 and 23% had scale 70-80. stream endobj IRO = Integrated radiology and oncologist assessment using RECIST 1.1, The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. The median time to onset of pneumonitis was 3.9 months (range 2 days to 27.2 months). 9 0 obj You can change your cookie settings at any time. No dose reductions of KEYTRUDA are recommended. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. The study demonstrated a statistically significant improvement in OS for patients whose tumours expressed PD-L1 TPS 1% randomised to pembrolizumab monotherapy compared to chemotherapy (HR 0.82; 95% CI 0.71, 0.93 at the final analysis) and in patients whose tumours expressed PD-L1 TPS 50% randomised to pembrolizumab monotherapy compared to chemotherapy. Based on the stratified Cox regression model, 0086 136 9073 4191. [email protected]. No patients experienced hepatic VOD. KEYNOTE-006: Controlled study in melanoma patients nave to treatment with ipilimumab. Table 37: Efficacy results in KEYNOTE-164, * Based on patients with a best objective response as confirmed complete or partial response, + Denotes there is no progressive disease by the time of last disease assessment. Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract. NOTE: for RCC patients treated with pembrolizumab in combination with axitinib with liver enzyme elevations, see dosing guidelines following this table. 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. Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Want to buy mhra spc,we are best mhra spc suppliers,manufacturers,wholesalers from China. 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. Participants are being followed for up to 12 months after the primary vaccination series for assessments of safety and efficacy against COVID-19. << 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), Nodular-sclerosis was the more represented cHL histological subtype (~ 81%) and bulky disease, B symptoms and bone marrow involvement were present in approximately 21%, 28% and 4% of patients, respectively. /ColorSpace 30 0 R It must be administered by infusion over 30 minutes. 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Dont worry we wont send you spam or share your email address with anyone. In patients with cHL (n=389) the incidence of hypothyroidism was 17%, all of which were Grade 1 or 2. Placebo on Day 1 every 3 weeks in combination with nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 every 28 days, or paclitaxel 90 mg/m2 on Days 1, 8, and 15 every 28 days, or gemcitabine 1,000 mg/m2 and carboplatin AUC 2 mg/mL/min on Days 1 and 8 every 21 days. Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg bw every 3 weeks, and 400 mg every 6 weeks (see section 4.2). 234, Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group and age strata as fixed effects and robust error variance, where VE = 100 (1 relative risk) (Zou 2004). Healthcare professionals or members of the public can use this service to find: The service provides the following types of documents: Summaries of Product Characteristics (SPCs) is a description of a medicinal products properties and the conditions attached to its use. /Contents 19 0 R /ExtGState 32 0 R You have accepted additional cookies. Colitis resolved in 130 patients, 2 with sequelae. The Kaplan-Meier curve for EFS and OS are shown in Figures 32 and 33. Secondary efficacy outcome measures were objective response rate (ORR) and response duration. 2. Secondary efficacy outcome measures were duration of response, PFS, and OS. 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. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Based on patients with a best objective response as confirmed complete or partial response. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2). << /MediaBox [0 0 595 842] 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. *produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species. The primary efficacy outcome measures were OS and PFS as assessed by BICR using RECIST 1.1. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. Monitor for the development or worsening KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). When reporting, please include the vaccine brand and batch/lot number, if available. See section 4.8 for how to report adverse reactions. The presence of a minor infection and/or low-grade fever should not delay vaccination. The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). 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. The KEYNOTE-581 study was not powered to evaluate efficacy of individual subgroups. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. The study demonstrated a statistically significant improvement in OS and PFS for all pre-specified study populations. KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. Close observation for at least 15 minutes is recommended following vaccination. Hyperthyroidism resolved in 315 (79.9%) patients, 11 with sequelae. /MediaBox [0 0 595 842] 2, Higher frequencies of these events were observed after the second dose. Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8). A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscularly approximately 6months after the primary series of Nuvaxovid in individuals 18years of age and older (homologous booster dose). Go to Products website to find information on medicines. Based on best response of stable disease or better, 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. Based on patients with a best objective response as confirmed complete or partial response, Sixty-one percent of patients had received ASCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 37% of patients had prior radiation therapy. For efficacy data in patients 75 years of age please refer to the relevant section of each indication. The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind study, KEYNOTE-189. At the time of this analysis, the Delta (B.1.617.2 and AY lineages) variant of concern (VOC) was the predominant variant circulating in the US and accounted for all cases from which sequence data are available (11/20, 55%). Manufacturing and Import authorisations. Patients were randomised (2:1) to receive one of the following regimens: Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=410), Placebo with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=206). Assessed by BICR using RECIST 1.1, Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). /Parent 3 0 R It is unknown whether Nuvaxovid is excreted in human milk. /Resources 28 0 R Nominal p-Value based on stratified log-rank test, Based on patients with a best objective response as confirmed complete or partial response. 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And/Or supportive care send You spam or share your email address with anyone is administered via the route...