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Update including FDA Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis1Known PDUFA Dates: 10Mar2020 - Opdivo+Yervoy for Previously Treated Hepatocellular Carcinoma (PT HCC) 25Mar2020 - Ozanimod for Relapsing-Remitting Multiple Sclerosis (RR MS) 4Apr2020 - Luspatercept for Low-Intermediate Risk RS+ MDS (MDS RS+) 26Jun2020 - EU approves Luspatercept for BT and MDS RS+) 15May2020 - Opdivo+Yervoy for First Line Non-Small Cell Lung Cancer (1L NSCLC) 15May2020 - Pomalyst for AIDS-related and HIV-negative Karposi's Sarcoma based on Phase I/II trial data 26May2020 - Opdivo+Yervoy for 1L NSCLC with limited chemotherapy w/o EGFR or ALKK approved earlier with original PDUFA 6Aug2020 based on CheckMate-9LA 27May2020 Zeposia/Ozanimod approved by EU for RRMS 10Jun2020 Opdivo approved for Advanced Esophageal Squamous Cell Carcinoma (ESCC) after Fluoropyrimidine and Platinum-based Chemotherapy 1Sep2020 - CC-486 for AML Maintenance of Adult Patients in Remission (Onureg) 18Sep2020 - Opdivo+Yervoy Receives Positive CHMP Opinion for 1L NSCLC with 2 Cycles of Chemotherapy 2Oct2020 - FDA Approval of Opdivo+Yervoy in Previously Treated Malignant Pleural Mesothelioma 19Oct2020 FDA Accepts Opdivo+Cabo for Priority Review in 1L RCC PDUFA 20Feb2020 6Nov2020 EU Approval of Opdivo+Yervoy with Two Cycles of Chemotherapy in 1L NSCLC 24Nov2020 EU Approval of Opdivo as Second Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma 30Dec2020 BMY Withdraws Opdivo as Third Line Small Cell Lung Cancer Treatment in U.S 2021: 4Jan2021 EMA Validates BMY's Opdivo Application as Treatment for Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiation 4Jan2021 EMA Validates BMY's Opdivo+Chemotherapy Application as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma 20Jan2021 FDA Accepts with Priority Review BMY's Opdivo Application as Treatment for Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiation with 20May2021 PDUFA date 20Jan2021 FDA Accepts with Priority Review BMY's Opdivo+Chemotherapy Application as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma with 25May2021 PDUFA date 22Jan2021 FDA Approves Opdivo+Cabo in 1L RCC PDUFA 1Feb2021 FDA Accepts with Priority Review BMY's Zeposia Ulcerative Colitis sNDA with 30May2021 PDUFA Date 4Feb2021 FDA Approves Liso-Cel CD-19 CAR-T for Adults with Relapsed or Refractory Large B-Cell Lymphoma 8Feb2021 EC Approves Inrebic/Fedratinib for Adult Newly Diagnosed and Previously Treated Myelofibrosis 26Feb2021 CHMP Positive Opinion for Opdivo+Cabo in 1L RCC 19Mar2021 FDA Accepts Application for Mavacantem in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) with 28Jan2022 PDUFA date 25Mar2021Japan’s Ministry of Health, Labour and Welfare Approves Breyanzi, a New CAR T Cell Therapy 26Mar2021 FDA Approves BMY/BLUE's ABECMA/Ide-cel, the first BCMA CAR-T for Relapsed/Refractory Multiple Myeloma (RRMM) 29Mar2021 EMA Validates BMY's Application for Opdivo/Nivo as Adjuvant Treatment in Muscle-Invasive Urothelial Cancer 14Apr2021 EC Approves Opdivo/Nivo + Cabo in 1L RCC 16Apr2021 FDA Approves Opdico/Nivo +Chemotherapy as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma ahead of 25May2021 PDUFA date 22Apr2021 CHMP Positive Opinion for Opdivo/Nivo+Yervoy/Ipi as First Line Treatment for Unsectable Malignant Pleural Mesothelioma 22Apr2021 CHMP Positive Opinion for Onureg/CC-486 as Frontline Oral Maintenace Therapy for Adults with Acute AML in First Remission 20May2021 FDA Approves Opdivo/Nivo as Adjuvant Therapy of Completely Resected Esophageal or Gastroesophageal Junction Cancer Patients who Received Neoadjuvant Chemoradiotherapy 21May2021 CHMP Positive Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy 27May2021 FDA Known PDUFA Dates: 10Mar2020 - Opdivo+Yervoy for Previously Treated Hepatocellular Carcinoma (PT HCC) 25Mar2020 - Ozanimod for Relapsing-Remitting Multiple Sclerosis (RR MS) 4Apr2020 - Luspatercept for Low-Intermediate Risk RS+ MDS (MDS RS+) 26Jun2020 - EU approves Luspatercept for BT and MDS RS+) 15May2020 - Opdivo+Yervoy for First Line Non-Small Cell Lung Cancer (1L NSCLC) 15May2020 - Pomalyst for AIDS-related and HIV-negative Karposi's Sarcoma based on Phase I/II trial data 26May2020 - Opdivo+Yervoy for 1L NSCLC with limited chemotherapy w/o EGFR or ALKK approved earlier with original PDUFA 6Aug2020 based on CheckMate-9LA 27May2020 Zeposia/Ozanimod approved by EU for RRMS 10Jun2020 Opdivo approved for Advanced Esophageal Squamous Cell Carcinoma (ESCC) after Fluoropyrimidine and Platinum-based Chemotherapy 1Sep2020 - CC-486 for AML Maintenance of Adult Patients in Remission (Onureg) 18Sep2020 - Opdivo+Yervoy Receives Positive CHMP Opinion for 1L NSCLC with 2 Cycles of Chemotherapy 2Oct2020 - FDA Approval of Opdivo+Yervoy in Previously Treated Malignant Pleural Mesothelioma 19Oct2020 FDA Accepts Opdivo+Cabo for Priority Review in 1L RCC PDUFA 20Feb2020 6Nov2020 EU Approval of Opdivo+Yervoy with Two Cycles of Chemotherapy in 1L NSCLC 24Nov2020 EU Approval of Opdivo as Second Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma 30Dec2020 BMY Withdraws Opdivo as Third Line Small Cell Lung Cancer Treatment in U.S 2021: 4Jan2021 EMA Validates BMY's Opdivo Application as Treatment for Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiation 4Jan2021 EMA Validates BMY's Opdivo+Chemotherapy Application as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma 20Jan2021 FDA Accepts with Priority Review BMY's Opdivo Application as Treatment for Adjuvant Treatment for Resected Esophageal or Gastroesophageal Junction Cancer Following Chemoradiation with 20May2021 PDUFA date 20Jan2021 FDA Accepts with Priority Review BMY's Opdivo+Chemotherapy Application as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma with 25May2021 PDUFA date 22Jan2021 FDA Approves Opdivo+Cabo in 1L RCC PDUFA 1Feb2021 FDA Accepts with Priority Review BMY's Zeposia Ulcerative Colitis sNDA with 30May2021 PDUFA Date 4Feb2021 FDA Approves Liso-Cel CD-19 CAR-T for Adults with Relapsed or Refractory Large B-Cell Lymphoma 8Feb2021 EC Approves Inrebic/Fedratinib for Adult Newly Diagnosed and Previously Treated Myelofibrosis 26Feb2021 CHMP Positive Opinion for Opdivo+Cabo in 1L RCC 19Mar2021 FDA Accepts Application for Mavacantem in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) with 28Jan2022 PDUFA date 25Mar2021Japan’s Ministry of Health, Labour and Welfare Approves Breyanzi, a New CAR T Cell Therapy 26Mar2021 FDA Approves BMY/BLUE's ABECMA/Ide-cel, the first BCMA CAR-T for Relapsed/Refractory Multiple Myeloma (RRMM) 29Mar2021 EMA Validates BMY's Application for Opdivo/Nivo as Adjuvant Treatment in Muscle-Invasive Urothelial Cancer 14Apr2021 EC Approves Opdivo/Nivo + Cabo in 1L RCC 16Apr2021 FDA Approves Opdico/Nivo +Chemotherapy as First Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma ahead of 25May2021 PDUFA date 22Apr2021 CHMP Positive Opinion for Opdivo/Nivo+Yervoy/Ipi as First Line Treatment for Unsectable Malignant Pleural Mesothelioma 22Apr2021 CHMP Positive Opinion for Onureg/CC-486 as Frontline Oral Maintenace Therapy for Adults with Acute AML in First Remission 20May2021 FDA Approves Opdivo/Nivo as Adjuvant Therapy of Completely Resected Esophageal or Gastroesophageal Junction Cancer Patients who Received Neoadjuvant Chemoradiotherapy 21May2021 CHMP Positive Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy 27May2021 FDA Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis1 Important CVR-Related BLA Filing: 16Nov2020 - Liso-cel/JCAR017 for Relapsed/Refractory Large B-Cell Lymphoma (RR DLBCL) - did not meet delayed PDUFA due to FDA not inspecting Lonza vector site 17Jul2020 EMA Validates Liso-cel/JCAR017 Application for Relapsed/Refractory Large B-Cell Lymphoma (RR DLBCL) starting maximum 150 days review w/PRIME designation 27Mar2021 Ide-cel/bb2121 for Fourth Line or Greater Relapsed/Refractory Multiple Myeloma(4L+ RR MM) accepted by FDA with Priority Review (superceded by 25Mar2021 FDA approbal) 1Jan2021 CVR Terminated by BMY as a Result of Liso-cel Not Gaining FDA Approval by 31Dec2020 Phase III CheckMate-9ER Opdivo+EXEL's TKI Cabozantinib hits both PFS and OS on 20Apr2020, presented at ESMO2020 19Sep2020 Phase III CheckMate-743 Opdivo+Yervoy hits OS primary endpoint in Previously Untreated Malignant Pleural Mesothelioma on 20Apr2020 11Aug2020 CheckMate-577 Opdivo hits DFS primary endpoint as Adjuvant Therapy in Resected Esophageal or Gastroesophageal Junction Cancer 11Aug2020 CheckMate-649 Opdivo+Chemotherapy hits both OS and PFS primary endpoints in 1L gastric and esophageal cancers 24Sep2020 CheckMate-274 Nivo/Opdivo improves DFS vs Placebo as Adjuvant Therapy for patients with High Risk Muscle-Invasive Urothelial Carconoma 7Oct2020 CheckMate -816 Phase III Opdivo/Nivo+Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response (pCR) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer (NSCLC) 16Oct2020 Positive CHMP Opinion Recommending Nivo/Opdivo as Second Line Treatment for Unresectable, Advanced or Metastatic Esophageal Squamous Cell Carcinoma 11Dec2020 Inrebic/Fedratinib CHMP Recommendation for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis There are numerous Life Cycle Management (LCM) read-outs in 2020/2021 for a variety of compounds including: High profile Ozanimod in Ulcerative Colitis (UC) based on Phase III TRUE NORTH trial met PEP with p<0.0001 and also met SEP on 2Jun2020 3Nov2020 - Highly anticipated Deucravacitinib/BMS-986165 oral TYK-2 in Psoriatic Arthritis (PsA) demonstrates superiority in PEP and key SEP in pivotal head-to-head trial versus Apremilast/Otezla 2021: 2Feb2021 High profile Deucravacitinib/BMS-986165 oral TYK-2 in Psoriatic Arthritis (PsA) demonstrates superiority in PEP and key SEP in pivotal head-to-head trial versus Apremilast/Otezla and Placebo 25Mar2021 Opdivo + anti-LAG3 antibody Relatlinib meet PFS primary endpoint (PEP) based on Phase II/III RELATIVITY-047 in previous untreated or unresectable melanoma 9apr2021 Opdivo/Nivo + Chemotherapy and Opdivo + Yervoy/Ipi Demonstrate Superior Survival Compared to Chemotherapy in Unresectable or Advanced Esophageal Squamous Cell Carcinoma (based on CheckMate 648) A variety of immuno-oncology (I/O) Opdivo/Yervoy indications in both the metastatic and adjuvant settings. Important CVR-Related BLA Filing: 16Nov2020 - Liso-cel/JCAR017 for Relapsed/Refractory Large B-Cell Lymphoma (RR DLBCL) - did not meet delayed PDUFA due to FDA not inspecting Lonza vector site 17Jul2020 EMA Validates Liso-cel/JCAR017 Application for Relapsed/Refractory Large B-Cell Lymphoma (RR DLBCL) starting maximum 150 days review w/PRIME designation 27Mar2021 Ide-cel/bb2121 for Fourth Line or Greater Relapsed/Refractory Multiple Myeloma(4L+ RR MM) accepted by FDA with Priority Review (superceded by 25Mar2021 FDA approbal) 1Jan2021 CVR Terminated by BMY as a Result of Liso-cel Not Gaining FDA Approval by 31Dec2020 Phase III CheckMate-9ER Opdivo+EXEL's TKI Cabozantinib hits both PFS and OS on 20Apr2020, presented at ESMO2020 19Sep2020 Phase III CheckMate-743 Opdivo+Yervoy hits OS primary endpoint in Previously Untreated Malignant Pleural Mesothelioma on 20Apr2020 11Aug2020 CheckMate-577 Opdivo hits DFS primary endpoint as Adjuvant Therapy in Resected Esophageal or Gastroesophageal Junction Cancer 11Aug2020 CheckMate-649 Opdivo+Chemotherapy hits both OS and PFS primary endpoints in 1L gastric and esophageal cancers 24Sep2020 CheckMate-274 Nivo/Opdivo improves DFS vs Placebo as Adjuvant Therapy for patients with High Risk Muscle-Invasive Urothelial Carconoma 7Oct2020 CheckMate -816 Phase III Opdivo/Nivo+Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response (pCR) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer (NSCLC) 16Oct2020 Positive CHMP Opinion Recommending Nivo/Opdivo as Second Line Treatment for Unresectable, Advanced or Metastatic Esophageal Squamous Cell Carcinoma 11Dec2020 Inrebic/Fedratinib CHMP Recommendation for Adult Patients with Newly Diagnosed and Previously Treated Myelofibrosis There are numerous Life Cycle Management (LCM) read-outs in 2020/2021 for a variety of compounds including: High profile Ozanimod in Ulcerative Colitis (UC) based on Phase III TRUE NORTH trial met PEP with p<0.0001 and also met SEP on 2Jun2020 3Nov2020 - Highly anticipated Deucravacitinib/BMS-986165 oral TYK-2 in Psoriatic Arthritis (PsA) demonstrates superiority in PEP and key SEP in pivotal head-to-head trial versus Apremilast/Otezla 2021: 2Feb2021 High profile Deucravacitinib/BMS-986165 oral TYK-2 in Psoriatic Arthritis (PsA) demonstrates superiority in PEP and key SEP in pivotal head-to-head trial versus Apremilast/Otezla and Placebo 25Mar2021 Opdivo + anti-LAG3 antibody Relatlinib meet PFS primary endpoint (PEP) based on Phase II/III RELATIVITY-047 in previous untreated or unresectable melanoma 9apr2021 Opdivo/Nivo + Chemotherapy and Opdivo + Yervoy/Ipi Demonstrate Superior Survival Compared to Chemotherapy in Unresectable or Advanced Esophageal Squamous Cell Carcinoma (based on CheckMate 648) A variety of immuno-oncology (I/O) Opdivo/Yervoy indications in both the metastatic and adjuvant settings. |
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