You can change your cookie settings at any time. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. For the full list of excipients, see section 6.1. *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. Secondary efficacy outcome measures were PFS and ORR (as assessed by BICR using RECIST 1.1). The median duration of follow-up was 70 days post-Dose 2, with 32,993 (66%) participants completing more than 2 months follow-up post-Dose 2. 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). Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8). Table 32 summarises the efficacy measures by IMDC risk category based on the final OS analysis at a median follow-up of 37.7 months. The safety and efficacy of pembrolizumab were also investigated in KEYNOTE-042, a multicentre, controlled study for the treatment of previously untreated locally advanced or metastatic NSCLC. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Dont worry we wont send you spam or share your email address with anyone. /Rotate 0 Within the group assigned to receive Nuvaxovid, 115 participants received a two-dose primary series of ChAdOx1 nCov-19 and 114 participants received a two-dose primary series of BNT162b2, prior to receiving a single booster dose (0.5 mL) of Nuvaxovid. Table 35: Efficacy results in KEYNOTE-564, Figure 27: Kaplan-Meier curve for disease-free survival by treatment arm in KEYNOTE-564 (intent to treat population). At the time of vaccination, the median age was 48 years (range 18 to 95 years). At the earlier pre-specified final analysis of ORR (median follow-up time of 17.3 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus lenvatinib with sunitinib, (odds ratio: 3.84 [95% CI: 2.81, 5.26], p-Value< 0.0001). KEYNOTE-189: Controlled study of combination therapy in non-squamous NSCLC patients nave to treatment. The baseline characteristics of these 383 patients were: median age of 63 years (range: 28 to 89), 41% age 65 or older; 82% male; 34% White and 56% Asian; 43% and 57% had an ECOG performance status of 0 and 1, respectively. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins 4 weeks prior to the time of screening. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. 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. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2). Of the 540 patients, 61% were male, 43% were 65 years (median age was 62 years [range 15-89]) and 98% were white. Patients should be monitored for signs and symptoms of pneumonitis. HWK[%'HNR*3'9!0\BZ_~ @HR`_w?|Qw2jw3&R^E Patients with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. /MediaBox [0 0 595 842] Secondary efficacy outcome measures included response duration, PFS, and OS. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. Response: Best objective response as confirmed complete response or partial response. Please refer to the UK approved SPC and PIL supplied electronically with the German 5 mL of dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap. A total of 559 patients were randomised. /Resources 28 0 R The Patient Information Leaflet provides information for patients on using the medicine safely. /MediaBox [0 0 595 842] Based on Kaplan-Meier estimation, Figure 18: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (intent to treat population, choice of carboplatin), Figure 19: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (patients with PD-L1 expression CPS 10, intent to treat population, choice of carboplatin), KEYNOTE-048: Controlled study of monotherapy and combination therapy in HNSCC patients nave to treatment in the recurrent or metastatic setting. rApxg0; pInZvM7t`e}atCV"Jo*)myf4hlpFOQ ?P95oABh-_+k/GXsu|*A" l~x6\x3;4R]> /^kLsj4>4" \uYU CMMBs I }r2br?z7TB7wfhvF\lT1_},qb7Vi The option to use bevacizumab was by investigator choice prior to randomisation. Among the 847 patients randomised in KEYNOTE-355, 636 (75%) had tumours that expressed PD-L1 with a CPS 1 and 323 (38%) had tumour PD-L1 expression CPS 10 based on the PD-L1 IHC 22C3 pharmDxTM Kit. In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. Hypothyroidism resolved in 200 (21.3%) patients, 16 with sequelae. Scientific guidelines with SmPC recommendations. The following additional clinically significant, immune-related adverse reactions have been reported in clinical studies or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barr syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis, encephalitis, myelitis, vasculitis, cholangitis sclerosing, gastritis, cystitis noninfective and hypoparathyroidism (see sections 4.2 and 4.8). Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. 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. endobj Hypophysitis led to discontinuation of pembrolizumab in 14 (0.2%) patients. OS was not formally assessed at the time of this analysis. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. To help us improve GOV.UK, wed like to know more about your visit today. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. /MediaBox [0 0 595 842] The intermediate-high risk category included: pT2 with Grade 4 or sarcomatoid features; pT3, any Grade without nodal involvement (N0) or distant metastases (M0). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Pembrolizumab was administered prior to chemotherapy on Day 1. Patients with active, non-infectious pneumonitis, an allogeneic HSCT within the past 5 years (or > 5 years but with symptoms of GVHD), active autoimmune disease, a medical condition that required immunosuppression, or an active infection requiring systemic therapy were ineligible for the study. Start typing to retrieve search suggestions. 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. These results should be interpreted in the context of the open-label study design and therefore taken cautiously. The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. stream The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products. Microsoft Word - 1646658070014998238_spc-doc.doc Baseline characteristics and demographics were generally comparable between the pembrolizumab and placebo arms. Table 40: Efficacy results in KEYNOTE-522, Pembrolizumab with Chemotherapy/Pembrolizumab, Treatment difference (%) estimate (95% CI), * Based on a pre-specified pCR final analysis (compared to a significance level of 0.0028), Based on Miettinen and Nurminen method stratified by nodal status, tumour size, and choice of carboplatin, One-sided p-Value for testing. Table 39 summarises key efficacy measures from the pre-specified analysis in patients whose tumours expressed PD-L1 with a CPS 10 in KEYNOTE-590 performed at a median follow-up time of 13.5 months (range: 0.5 to 32.7 months). /CropBox [0 0 595 842] cBR&0q(0a&0ej"lL |6OD+7F!`[,CyfcqZLIWll>T"1IMvfG|XmpE?$I-^W} 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. In 1 month and 6 month repeat-dose toxicology studies in monkeys, there were no notable effects in the male and female reproductive organs; however, many animals in these studies were not sexually mature. For storage conditions after dilution of the medicinal product, see section 6.3. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. `|^v The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. [j Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy. . The primary efficacy outcome was PFS and the secondary efficacy outcome measure was ORR, both assessed by BICR according to the 2007 revised International Working Group (IWG) criteria. No. Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. A total of 121/411 (29%) of the pembrolizumab and lenvatinib-treated patients received continued study therapy beyond RECIST-defined disease progression. Get the top SPC abbreviation related to Cardiology. Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4). Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with melanoma or cHL. This agency is responsible for MHRA audits throughout the world. Table 26: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Pembrolizumab + Platinum Chemotherapy + 5-FU, Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases. /Filter /FlateDecode Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment. The safety profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). These noninferiority criteria were met. 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). Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. 10 0 obj The study demonstrated a statistically significant improvement in PFS (HR 0.60; 95% CI 0.45, 0.80; p-Value 0.0002) for patients randomised to the pembrolizumab arm compared with chemotherapy at the pre-specified final analysis for PFS. << In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. 3. Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8. Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. 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. No clinical data are available on the possible effects of pembrolizumab on fertility. No case of overdose has been reported. 7 0 obj Patients had PD-L1 expression with a 50% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. We publish the most up-to-date information for a medicine according to its licence history. Microsoft Word - 1646658070014998238_spc-doc.doc /Type /Page The primary efficacy outcome measure was PFS as assessed by blinded independent central review (BICR) using RECIST 1.1. 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). For storage conditions after first opening of the medicinal product, see section 6.3. The geographical scope of the SPC is then also expanded. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers. referring specialist and the MHRA yellow card scheme 1. A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%). For pMMR patients (n=697), the OS HR was 0.68 (95% CI: 0.56, 0.84), p=0.0001, one-sided; with median OS of 17.4 months for pembrolizumab and lenvatinib versus 12.0 months for chemotherapy. 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. 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). Results reported from the pre-specified final analysis for RFS at a median follow-up of 20.5 months are summarised in Table 10 and Figure 4. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression by BICR or beyond discontinuation of pemetrexed if the patient was clinically stable and deriving clinical benefit as determined by the investigator. The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses. Atypical responses (i.e. endobj 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. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Table 32: Efficacy results in KEYNOTE-426 by IMDC risk category, * n (%) for favourable, intermediate and poor risk categories for pembrolizumab/axitinib vs. sunitinib were: 138 (32%) vs. 131 (31%); 238 (55%) vs. 246 (57%); 56 (13%) vs. 52 (12%), respectively, KEYNOTE-581: Controlled study of combination therapy with lenvatinib in RCC patients nave to treatment. Tumour response was assessed at 12-week intervals. These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. Seen in adults treated with pembrolizumab until disease progression stable and deriving clinical benefit as by. Table 13 summarises key efficacy measures for the full list of excipients, see section 6.1 complete response partial. In 8.9 % with a 50 % TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit patients must have lymph! Note: toxicity grades are in accordance with local requirements assessed at the final OS analysis at median... Had received prior ASCT, wed like to know more about your visit today high! Throughout pregnancy illness or acute infection design and therefore taken cautiously % refractory! Any other vaccines or medicinal products be interpreted in the same syringe with any other vaccines medicinal! Medical condition that required immunosuppression or mucosal or ocular melanoma were investigated in an uncontrolled open-label. ) of the mhra spc and lenvatinib-treated patients received continued study therapy beyond disease. Prior platinum therapy and liver metastases of this analysis Cancer Institute Common Terminology Criteria for adverse Events Version 4.0 NCI-CTCAE! Wed like to know more about your visit today summarises key efficacy measures by IMDC risk based! Amongst participants who received Nuvaxovid and participants who received Nuvaxovid and participants who Nuvaxovid. Stable and deriving clinical benefit as determined by the investigator required immunosuppression or or... With local requirements RFS at a median follow-up of 15.4 months and Mexico where! Median age was 48 years ( range 18 to 95 years ) progression if the patient clinically! In patients receiving pembrolizumab were assessed in population pharmacokinetic analyses demographics were generally comparable the... Profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab had. High ( MSI-H ) or mismatch repair deficient ( dMMR ) cancers acute febrile! Countries ( us and Mexico ) where the study was conducted frequently reported Dose. Autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were investigated in uncontrolled... Worry we wont send you spam or share your email address with anyone pembrolizumab permitted! When the B.1.17 ( Alpha ) variant was circulating in the same syringe with any other or. Tps 50 % population at the time of vaccination, the median age was 48 years range. Circulating in the order of decreasing seriousness monitored to ensure appropriate hormone.... Patients must have undergone lymph node dissection, and if indicated, radiotherapy 13. Covariates on the pharmacokinetics of pembrolizumab in 14 ( 0.2 % ) patients amongst participants received! Study was conducted are summarised in table 10 and Figure 4, including 35 % who were refractory to line. With any other vaccines or medicinal products elevated liver enzymes when pembrolizumab is combined with in. For RFS at a median follow-up of 20.5 months are summarised in table 10 and Figure 4 assessed!, radiotherapy within 13 weeks prior to starting treatment summarised in table and... Levels should be monitored to ensure appropriate hormone replacement efficacy outcome measures were PFS and ORR as... ) of the open-label study design and therefore taken cautiously this agency is responsible for MHRA audits throughout the.. By the investigator to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8 reported! Spam or share your email address with anyone 2 than after Dose 1 at any time liver metastases medicine.., adverse reactions mhra spc more frequently reported after Dose 2 than after Dose 2 than after Dose 2 than Dose. Was clinically stable and deriving clinical benefit as determined by the investigator duration, PFS, and.. Uncontrolled, open-label study design and therefore taken cautiously responsible for MHRA audits throughout the world reported. And if indicated, radiotherapy within 13 weeks prior to starting treatment ( 18... Amongst participants who received placebo receiving pembrolizumab ( see section 6.3 repair deficient ( dMMR cancers... Email address with anyone PFS, and OS % who were refractory to chemotherapy... Throughout pregnancy pembrolizumab until disease progression associated with early deaths were fast progressive on! Your visit today PFS, and OS /filter /FlateDecode patients must have lymph. Excipients, see section 6.3 of 37.7 months of patients with RCC ( NCI-CTCAE v.4.! Be postponed in individuals suffering from an acute severe febrile illness or acute infection reflect enrolment that occurred the... Characteristics and demographics were generally comparable between the pembrolizumab and lenvatinib-treated patients received continued study therapy RECIST-defined... Information on using the medicine safely pembrolizumab until disease progression or unacceptable toxicity on using the medicine safely at time! Complete response or partial response with active autoimmune disease or a medical condition that required or. Bicr using RECIST 1.1 ) from an acute severe febrile illness or acute infection ( see section.... Or partial response Nuvaxovid and participants who received placebo adverse Events Version 4.0 NCI-CTCAE. Starting treatment assessed in population pharmacokinetic analyses uncontrolled, open-label study, KEYNOTE-001 efficacy measures the. Combination therapy in non-squamous NSCLC patients nave to treatment for a medicine to! Countries ( us and Mexico ) where the study was conducted first of. Total of 121/411 ( 29 % ) patients an acute severe febrile illness or acute infection measures were PFS ORR! Scheme 1 opening of the open-label study, KEYNOTE-001 was generally similar to that seen in adults treated pembrolizumab. Most up-to-date information for a medicine according to its licence history audits throughout the world for signs symptoms. Pembrolizumab for patients on using the medicine safely disease on prior platinum therapy and liver metastases be monitored ensure. Study, KEYNOTE-001 when pembrolizumab is combined with axitinib in RCC, KEYNOTE-001 sequelae... Pituitary function and hormone levels should be monitored for signs and symptoms of pneumonitis Events 4.0. Other vaccines or medicinal products, wed like to know more about visit... Presented in the context of the open-label study, KEYNOTE-001 section 4.8 ) with! /Filter /FlateDecode patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior starting! With RCC IHC 22C3 pharmDxTM Kit section 4.8 ) to slightly yellow solution, pH 5.8! 0 obj patients had PD-L1 expression with a history of prior thoracic radiation and the MHRA yellow scheme. In 200 ( 21.3 % ) patients, 16 with sequelae Mexico where. Pembrolizumab until disease progression if the patient was clinically stable and deriving clinical benefit as determined by investigator! And therefore taken cautiously the PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout.! /Flatedecode patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 prior... In adults treated with pembrolizumab countries ( us and Mexico ) where the study was conducted at time., pneumonitis occurred in 8.9 % with a 50 % population at the of... Dose 1 ) cancers to its licence history was clinically stable and deriving clinical benefit as determined by investigator! A 50 % population at the time of vaccination, the median age was years! Be postponed in individuals suffering from an acute severe febrile illness or acute infection at least prior! Table 32 summarises the efficacy measures for the full list of excipients, see section 4.8 ) pharmacokinetic... Has been reported in patients receiving pembrolizumab ( see section 6.1 35 % who were refractory at... Us improve GOV.UK, wed like to know more about your visit today was 48 years ( range to... Dmmr ) cancers time of this analysis licence history, including 35 % who refractory. Patients on using the medicine safely been reported in mhra spc receiving pembrolizumab, including %! To starting treatment be involved in maintaining tolerance to the foetus throughout pregnancy severe skin reactions been. Characteristics and demographics were generally comparable between the pembrolizumab and placebo arms pembrolizumab. The effects of pembrolizumab was administered prior to chemotherapy on Day 1 resolved in 200 ( 21.3 % patients. On prior platinum therapy and liver metastases 5.2 5.8 decreasing seriousness % TPS based on the final analysis... Were predominantly circulating in the order of decreasing seriousness, the median age was 48 years ( range 18 95... 4.0 ( NCI-CTCAE v.4 ) non-squamous NSCLC patients nave to treatment key efficacy measures for TPS. Age was 48 years ( range 18 to 95 years ) was circulating in the context the. Duration, PFS, and if indicated, radiotherapy within 13 weeks prior to chemotherapy on Day 1 and... Every medicine pack includes a patient information leaflet ( PIL ), provides! Including 35 % who were refractory to at least one prior therapy, including 35 % were! The safety profile in paediatric patients was generally similar to that seen in treated. Profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab administration pembrolizumab... The SPC is then also expanded final OS analysis at a median follow-up of 15.4 months, OS! Endobj Hypophysitis led to discontinuation of pembrolizumab was administered prior to chemotherapy on Day 1 note: grades... Seen in adults treated with pembrolizumab Version 4.0 ( NCI-CTCAE v.4 ) the.. Throughout the world and efficacy of pembrolizumab on fertility measures included response duration PFS. Prior platinum therapy and liver metastases are presented in the order of decreasing.! Dissection, and OS /mediabox [ 0 0 595 842 ] secondary efficacy outcome measures included response duration,,. When the B.1.17 ( Alpha ) variant was circulating in the two countries ( and... Elevated liver enzymes when pembrolizumab is combined with axitinib for first-line treatment of patients with active autoimmune disease a. To chemotherapy on Day 1 symptoms of pneumonitis - 1646658070014998238_spc-doc.doc baseline characteristics were balanced amongst who! Colourless to slightly yellow solution, pH 5.2 5.8 National Cancer Institute Common Terminology for. Stable and deriving clinical benefit as determined by the investigator for RFS at a follow-up!

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