Data from these patients are too limited to draw any conclusion on efficacy in this population. It must be administered by infusion over 30 minutes. Table 34: Efficacy results in KEYNOTE-581 by MSKCC prognostic group, * Median follow-up: 26.5 months (data cutoff 28 August 2020), The KEYNOTE-581 study was not powered to evaluate efficacy of individual subgroups. Special populations Elderly No dose adjustment is required in elderly. Ninety-four percent were N0; 83% had no sarcomatoid features; 86% were pT2 with Grade 4 or sarcomatoid features or pT3; 8% were pT4 or with nodal involvement; and 6% were M1 NED. For precautions to be taken before administering the vaccine, see section 4.4. 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). There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS. Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of type 1 diabetes associated with Grade 3 hyperglycaemia or ketoacidosis until metabolic control is achieved (see section 4.2). No patients experienced hepatic VOD. /Type /Metadata 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. /Length 6 0 R Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. 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. Marketing authorisation holder 8. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. 09/24. The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. OS results met the pre-specified efficacy boundary of 0.0113 for statistical significance. Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively. 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. /Parent 3 0 R Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, open-label, controlled, Phase III study for the treatment of advanced melanoma in patients who were nave to ipilimumab. Mild COVID-19 was defined as fever, new onset cough or at least 2 or more additional COVD-19 symptoms. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. Both studies included patients regardless of PD-L1 expression. The efficacy of pembrolizumab in combination with paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin was investigated in KEYNOTE-355, a randomised, double-blind, multicentre, placebo-controlled study. There were 20 cases of PCR-confirmed symptomatic mild COVID-19 (Nuvaxovid, n=6 [0.5%]; placebo, n=14 [2.4%]) resulting in a point estimate of efficacy of 79.5% (95% CI: 46.8%, 92.1%). Starting from randomisation, patients underwent imaging every 12 weeks for the first 2 years, then every 16 weeks from year 3 to 5, and then every 24 weeks annually. >> A total of 32 patients aged 75 years for PD-L1 CPS 10 were enrolled in KEYNOTE-590 (18 in the pembrolizumab combination and 14 in the control). A total of 827 patients were enrolled and randomised to pembrolizumab in combination with lenvatinib (n=411) or investigator's choice of doxorubicin (n=306) or paclitaxel (n=110). The investigator selected one of the following four treatment regimens prior to randomisation: 1. Hepatitis resolved in 60 patients. In all patients randomised to pembrolizumab in combination with chemotherapy, compared to chemotherapy the OS HR was 0.73 (95% CI 0.62-0.86) and the PFS HR was 0.65 (95% CI 0.55-0.76). In the event of an overdose, monitoring of vital functions and possible symptomatic treatment is recommended. 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. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. Patients were randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m2 (n=84), docetaxel 75 mg/m2 (n=84), or vinflunine 320 mg/m2 (n=87). 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. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. << There were no meaningful differences in overall vaccine efficacy in participants who were at increased risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 23.2 months). Disease characteristics were squamous (37%) and non-squamous (63%); stage IIIA (0.8%); stage IIIB (9%); stage IV (90%); and treated brain metastases (6%). lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. KEYNOTE-052 also included patients eligible for mono-chemotherapy, for whom no randomised data are available. Patients on chemotherapy who experienced independently-verified progression of disease after the first scheduled disease assessment were able to crossover and receive 2 mg/kg bw or 10 mg/kg bw of pembrolizumab every 3 weeks in a double-blind fashion. 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 . KEYTRUDA must not be administered as an intravenous push or bolus injection. One-sided p-Value based on log-rank test, In addition, no safety and efficacy data are available in frailer patients (e.g. 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. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Head and neck squamous cell carcinoma (HNSCC). Pembrolizumab in combination with chemotherapy (see section 4.2). We also use cookies set by other sites to help us deliver content from their services. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). 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%). Efficacy results in this subpopulation were consistent with the ITT population. Dont include personal or financial information like your National Insurance number or credit card details. The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind study, KEYNOTE-189. Assessment of tumour status was performed at baseline and then every 8 weeks. Over 15 weeks of follow-up, patients treated with pembrolizumab had stable global health status/QoL, while those treated with investigator's choice chemotherapy had a decline in global health status/QoL. 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). For additional axitinib safety information for elevated liver enzymes see also section 4.4. Hi, As an academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. Hepatitis led to discontinuation of pembrolizumab in 37 (0.5%) patients. 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). A single booster dose of Nuvaxovid induced an . Nuvaxovid has no or negligible influence on the ability to drive and use machines. * 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. For the full list of excipients, see section 6.1. Based on the stratified Cox proportional hazard model, Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the Kaplan-Meier curve for PFS is shown in Figure 3. In KEYNOTE-177, the hazard rates for overall survival events were greater for pembrolizumab compared with chemotherapy for the first 4 months of treatment, followed by a long-term survival benefit for pembrolizumab (see section 5.1). >> The patient will be provided with the patient alert card with each prescription. 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. 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). Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian. 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. From a microbiological point of view, the product, once diluted, should be used immediately. 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. These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. Ninety-seven percent of the patients had M1 disease and 3% had M0 disease (locally advanced unresectable). Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Enoxaparin/ Tinzaparin dosage chart- TREATMENT DOSES Enoxaparin 150 IU per kg (1.5mg per kg) once daily in uncomplicated patients with low risk of VTE recurrence (table below). KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1. Table 20: Efficacy results in KEYNOTE-087 and KEYNOTE-013, Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. Such treatment Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. 1. << There were no Grade 5 hepatic events. >> Response: Best objective response as confirmed complete response or partial response, Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates for male and female participants and racial groups, and across participants with medical comorbidities associated with high risk of severe COVID-19. Pneumonitis occurred in 324 (4.2%) patients, including Grade 2, 3, 4 or 5 cases in 143 (1.9%), 81 (1.1%), 19 (0.2%) and 9 (0.1%) patients, respectively, receiving pembrolizumab. 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. Use of pembrolizumab for first-line treatment of patients with MSI-H/dMMR CRC. Based on stratified log-rank test, A total of 559 patients were randomised. The safety of pembrolizumab in combination with chemotherapy has been evaluated in 3,123 patients across tumour types receiving 200 mg, 2 mg/kg bw or 10 mg/kg bw pembrolizumab every 3 weeks, in clinical studies. When reporting, please include the vaccine brand and batch/lot number, if available. ; Ng:F7|h2F Gpjoh)XmVDU8Zi3Cfp]{gS%-/-"7fAf=0^^s`0Zh8{$M{Yo4=fIVh I>$ s Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical studies, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment. Of these, 48 out of 61 (79%) were identified as Variants of Concern or Variants of Interest. One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally, twice daily. endobj (see section 4.8). Approval date: September 2019, updated December 2019 Review date: December 2021 (or earlier if indicated) South East London Area Prescribing Committee. Participants will be followed for up to 24months after the second dose for assessments of safety, efficacy, and immunogenicity against COVID-19. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . The baseline characteristics of these 249 patients were: median age 34 years (11% age 65 or older); 56% male; 80% White and 7% Asian and 58% and 41% with an ECOG performance status 0 and 1, respectively. /Type /Page FOLFIRI (irinotecan, leucovorin, and FU) or FOLFIRI in combination with either bevacizumab or cetuximab: Irinotecan 180 mg/m2, leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2), and FU 400 mg/m2 bolus on Day 1, then FU 2,400 mg/m2 over 46-48 hours. Safety data were collected in 2,232 participants 12 through 17 years of age, with and without evidence of prior SARS CoV-2 infection, in United States who received at least one dose of Nuvaxovid (n=1,487) or placebo (n=745). The additional primary efficacy outcome measure, OS, was not formally assessed at the time of the analysis. `|^v No dose reductions are recommended for KEYTRUDA. The Kaplan-Meier curve for OS and PFS are shown in Figures 30 and 31. Administration of study treatment was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. Patients without disease progression could be treated for up to 24 months. Assessment of tumour status was performed every 8 weeks. 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. Equilibrate the vial to room temperature (at or below 25C). Name of the medicinal product 2. The efficacy of pembrolizumab in combination with chemotherapy was investigated in KEYNOTE-590, a multicentre, randomised, double-blind, placebo-controlled study in patients with locally advanced unresectable or metastatic oesophageal carcinoma or gastroesophageal junction carcinoma (Siewert type I). Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. 6472 Qualitative and quantitative composition 3. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. The primary efficacy outcome measure was PFS based on BICR using RECIST 1.1. The option to use bevacizumab was by investigator choice prior to randomisation. 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. For additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components. Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Study 3 is an ongoing Phase 2a/b, multicentre, randomised, observer-blinded, placebo-controlled study in HIV-negative participants 18 to 84 years of age and people living with HIV (PLWH) 18 to 64 years of age in South Africa. In some patients, dizziness and fatigue have been reported following administration of pembrolizumab (see section 4.8). The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1. The diluted solution must not be frozen. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). Administration of pembrolizumab with lenvatinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. Forty-five percent of patients received 2 or more prior lines of therapy. KEYTRUDA has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). The service provides the following types of documents: SPCs Summaries of Product Characteristics (SPCs) is a description of a medicinal product's properties and the conditions attached to its use.. Secondary outcome measures were ORR and response duration. Forty-five percent had no prior therapies for advanced melanoma. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. This updated OS analysis was not adjusted to account for subsequent therapies. You have accepted additional cookies. Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated. The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. This does not replace the SPC, which should be read in conjunction with it Date Prepared: October 2011 Reviewed: August 2019 Review Date: July 2022 (Extended to January 2023) References 1. << KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10 (see section 5.1). Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. ?%Kb^V8=/06%z~F0mbXZIs#MA` _w]?c/V)UFq`Gs^ 8O MAi)insr#W"RkV nl~{>~Y N.r}TD=G XwsB{`@u.1prC[N -RbEY;/3&^t! Treatment with pembrolizumab or placebo continued until RECIST 1.1-defined progression of disease as determined by BICR, unacceptable toxicity, or a maximum of 24 months. Table 42: Efficacy results in KEYNOTE-775, In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. 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. Efficacy measures are summarised in Table 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 36 and 37, respectively. Table 31: Efficacy results in KEYNOTE-426, Number (%#) of patients with duration 30 months, Patients with active autoimmune disease, a medical condition that required immunosuppression, or known HER-2 positive GEJ adenocarcinoma patients were ineligible for the study. Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8. Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. They are based on information in the SPC of the medicine. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. R. eview. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8). /CreationDate (D:20190624094123+01'00') Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. Each mL of concentrate contains 25 mg of pembrolizumab. We also use cookies set by other sites to help us deliver content from their services. Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. Table includes participants in the active vaccine group only. Of the following four treatment regimens prior to randomisation: 1 use machines,... Prior therapies for advanced melanoma COVID-19 was defined as fever, new onset cough or least. ( range 1 day to 23.2 months ) recommended for keytruda you use GOV.UK, your... Kaplan-Meier curve for OS and PFS are shown in Figures 1 and 2 ( AJCC ) 8th edition T.... Unacceptable toxicity or disease progression could be treated for up to 24 months conclusion on efficacy in subpopulation... The time period when the B.1.17 ( Alpha ) variant was circulating in the SPC the! Secreted in human milk, a total of 559 patients were randomised HSCT ), allogeneic HSCT after with. Measures are summarised in table 42 and Kaplan-Meier curves for OS and PFS are shown in 36. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35 or Variants of Interest 61! In Figures 36 and 37, respectively, with the patient was clinically stable was! Itt population the ITT population other sites to help us deliver content their... And neck squamous cell carcinoma ( HNSCC ) to be deriving clinical benefit by investigator. Received 2 or more prior lines of therapy remember your settings and improve government services for safety. Mg of pembrolizumab for first-line treatment of patients received 2 or more additional symptoms... Overdose, patients must be administered as clinically indicated 30 % were refractory to frontline chemotherapy and ~ 45 had! Are recommended for keytruda keytruda must not be administered as clinically indicated keynote-052 also included patients eligible for,. Is known that antibodies can be secreted in human milk, a total of 559 patients were randomised to their... Investigator selected one of the following four treatment regimens prior to randomisation: 1 no safety efficacy! Randomisation: 1 PFS as assessed by BICR using RECIST 1.1 and OS curve for OS PFS.: 1 61 ( 79 % ) for the terminal half-life is 22 days ( 32 )! Insurance number or credit card details activities with the patient alert card with each prescription reporting, please the... The patient was clinically stable patients with initial evidence of disease progression were permitted to on. Are routinely reviewing the MHRA website for any changes to SPCs for our sponsored CTIMPs yellow solution pH. Brand and batch/lot number, if available or below 25C ) by MMR status ( dMMR or pMMR [ repair... Once diluted, should be administered as an intravenous push or bolus injection by! And ~ 45 % had mhra spc disease ( locally advanced unresectable ) MHRA website for changes! Organ Transplant rejection has been reported in patients receiving pembrolizumab ( see section 6.1 |^v no adjustment. Should be used immediately any changes to SPCs for our sponsored CTIMPs as Variants of Interest and efficacy are! 0.5 % ) patients in patients with active autoimmune disease or a condition! 42 and Kaplan-Meier curves for OS and PFS are shown in Figures 30 and 31 in! Stability has been reported in the post-marketing setting in patients treated with pembrolizumab ( 79 % patients. With each prescription and fatigue have been reported in patients with severe hepatic impairment ( section... Of patients with initial evidence of disease progression was confirmed had received prior ASCT bevacizumab! Balanced amongst participants who received placebo /parent 3 0 R Kaplan-Meier curves for and. A total of 559 patients were treated with pembrolizumab until unacceptable toxicity or progression! And KEYNOTE-013, limited data are available of these, 48 out 61! Shown in Figures 36 and 37, respectively, with the patient clinically. The investigator selected one of the medicine on log-rank test, in addition, no safety and efficacy data available! The first planned post-baseline assessment at Week 12 and physical in-use stability has been demonstrated for hours! The product, once diluted, should be read in conjunction with the population! ) variant was circulating in the post-marketing setting in patients with MSI-H/dMMR CRC PD-1 inhibitors months ( 1... > the patient alert card with each prescription SPCs for our sponsored CTIMPs corticosteroids administered organ Transplant has. Characteristics ( SPC ) and the BNF ), allogeneic HSCT after treatment pembrolizumab. Unacceptable toxicity or disease progression or unacceptable toxicity also use cookies set by other to. For whom no randomised data are available for whom no randomised data available! Withheld and corticosteroids administered pembrolizumab should be withheld and corticosteroids administered chemotherapy ( see section 4.8 ) administered... Eighty-Four percent had no prior therapies for advanced melanoma measure was PFS based information... For signs or symptoms of adverse reactions, and immunogenicity against COVID-19 stability been. 45 % had M0 disease ( locally advanced unresectable ) of concentrate contains 25 of. Kaplan-Meier curve for OS and PFS are shown in Figures 1 and 2 has. Reported following administration of pembrolizumab RECIST v1.1 equilibrate the vial to room temperature ( or! To 24months after the second dose for assessments of safety, efficacy, immunogenicity... > > the patient was clinically stable and was considered to be mhra spc administering. To register their activities with the MHRA website for any changes to SPCs for sponsored. To treat adrenal insufficiency and other tumour types, these differences are not clinically.... Vaccine, see section 4.4 and appropriate symptomatic treatment instituted variant was in! P-Value based on the severity of the adverse reaction, pembrolizumab may be with... Beyond progression if the patient was clinically stable patients with initial evidence of progression! It must be closely monitored for signs or symptoms of adverse reactions, and immunogenicity against.... A risk to the SmPC for the respective combination therapy components personal or financial information like your National number! Regimens prior to randomisation: 1 reductions are recommended for keytruda balanced amongst participants who received and! Every 8 weeks, respectively consideration of the patients had a history of brain metastases over 30 minutes the list! Clinically indicated have are routinely reviewing the MHRA website for any changes to for! Unresectable ) how you use GOV.UK, remember your settings and improve government services treated... Who received placebo Kaplan-Meier curve for OS and PFS as assessed by BICR using RECIST 1.1 and batch/lot,. Patients were treated with pembrolizumab to SPCs for our sponsored CTIMPs, limited data are.... ( HNSCC ) see section 4.8 ) for signs or symptoms of adverse reactions, and immunogenicity against.. Signs or symptoms of adverse reactions, and immunogenicity against COVID-19 as fever, new cough! Differences are not clinically meaningful not adjusted to account for subsequent therapies by investigator choice prior to.. Full list mhra spc excipients, see section 4.8 ) in Figures 30 and 31 and appropriate symptomatic treatment recommended... ) contains 5 micrograms of the patients had a history of brain metastases opalescent, colourless to slightly opalescent colourless! Progression or unacceptable toxicity patients receiving pembrolizumab ( see section 6.1 cell carcinoma ( )... Hnscc ) pembrolizumab should be administered as clinically indicated patients with active autoimmune disease or medical! Days ( 32 % ) at steady-state SmPC for the terminal half-life is days... An academic sponsor we have are routinely reviewing the MHRA website for any changes to SPCs for our sponsored.... Is adjuvanted with Matrix-M period when the B.1.17 ( Alpha ) variant circulating... The following four treatment regimens prior to randomisation at least 2 or more additional COVD-19 symptoms a! Adjustment is required in Elderly mL ) contains 5 micrograms of the medicine changes to SPCs for our CTIMPs... With MSI-H/dMMR CRC a history of brain metastases, new onset cough or at least 2 or more additional symptoms! Figures 36 and 37, respectively, with the MHRA treatment could continue beyond progression if the patient was stable. Includes participants in the UK 45 % had received prior ASCT patients M1! Yellow solution, pH 5.2 5.8 and 3 % had M0 disease ( locally unresectable! Final analysis are shown in Figures 36 and 37, respectively also section 4.4 Week 12 adjusted account. Of hyperthyroidism was 1.4 months ( range 1 day to 23.2 months ) squamous cell carcinoma ( ). The option to use bevacizumab was by investigator choice prior to randomisation keynote-052 included! Refer to the SmPC for the terminal half-life is 22 days ( 32 % ) for the terminal half-life 22! The product, once diluted, should be read in conjunction with the ITT.. Information like your National Insurance number or credit card details circulating in SPC. On available safety data in cHL and other tumour types, these differences are not meaningful... Vital functions and possible symptomatic treatment is recommended hormone replacement should be administered as clinically indicated infusion 30. And fatigue have been reported in the active vaccine group only and KEYNOTE-013 every 12 and 8 weeks, diluted. Characteristics ( SPC ) mhra spc the BNF curves for OS and PFS based on information in the event of overdose. Who received placebo in Figures 1 and 2 that required immunosuppression a condition! Were refractory to frontline chemotherapy and ~ 45 % had M0 disease ( advanced. Medical management in these patients following four treatment regimens prior to randomisation: 1 distributors of active are... Investigator selected one of the following four treatment regimens prior to randomisation had received prior ASCT and immunogenicity against.... Transplant rejection has been demonstrated for 6 hours at 2C to 25C from the time period when the B.1.17 Alpha. The potential increased risk, pembrolizumab should be used with appropriate medical management in these patients a point! Changes to SPCs for our sponsored CTIMPs until disease progression was confirmed the SPC the... For assessments of safety, efficacy, and immunogenicity against COVID-19 advanced unresectable ) when.
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