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Update for Recent News re Adjuvant Opdivo Melanoma PDUFA&EU Reblozyl BT NTD ApprovalKnown 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 2Jun2021 EC Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma 18Jun2021 EC Approval for Onureg as Frontline Oral Maintenance for Adults with AML 25Jun2021 CHMP Positive Opinion on Abecma/Ide-cel for 4L RRMM 25Jun2021 CHMP Positive Opinion for Opdivo/Nivo as Adjuvant Therapy for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathological Disease after Chemotherapy 29Jun2021 EC Approval for Opdivo/Nivo plus Yervoy/Ipi for Treatment of Mismatch Repair Deficient or Microsatellite-Instability High Metastatic Colorectal Cancer after Chemotherapy 23Jul2021 BMY withdraws Opdivo/Nivo monotherapy post-Sorafenib in Hepatocellular Carcinoma (HCC) as result of negative AdCom and confirmatory trial CheckMate-459 not showing a statistically significant benefit (Opdivo + Yervoy is approved in this setting) 30Jul2021 EC Approval for Opdivo/Nivo as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer with Residual Pathological Disease after Chemoradiotherapy basedon CheckMate-577 19Aug2021 EC Approval for Abecma/Ide-cel the First Anti-BCMA CAR-T Therapy for Relapsed Refractory Multiple Myeloma 23Aug2021 FDA Accepts for Priority Review BMY's Application for Orencia/Abatercept for the Prevention of Acute Graft versus Host Disease (aGVHD) with 23Dec2021 PDUFA Date 17Sep2021 CHMP Positive Opinion on Opdivo/Nivo+Chemotherapy for Patients with HER2-Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS >=5 20Sep2021 FDA Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma w/PDUFA Date of 19Mar2022 27Sep2021 FDA Accepts Opdivo/Nivo+Yervoy/Ipi and Opdivo/Nivo+Chemotherapy for Unresectable, Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with PDUFA Date of 28May2022 1Oct2021 EMA Validates Application for Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) 1Oct2021EMA Validates Application for LAG-3 Blocking Antibody Relatlimab and Opdivo/Nivo Fixed Dose Combination as First Line Treatment for Patients with Unresectable or Metastatic Melanoma 15Oct2021 CHMP Positive Opinion for Zeposia/Ozanimod as Treatment for Adult Patients with Moderate to Severe Ulcerative Colitis(UC) 21Oct2021 EC Approval for Opdivo/Nivo + Chemotherapy for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma 19Nov2021 FDA Extends PDUFA to 28Apr2022 for Mavacamten Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) 23Nov2021 EC Approval of Zeopisa/Ozanimod for Use in Adults with Moderately to Severe Active Ulcerative Colitis (UC) 29Nov2021 FDA Assigns Target Action Date of 10Sep2021 Oral TYK2 Deucracitinib in Adults with Moderate to Severe Plaque Psoriasis 29Nov2021 EMA Validation of MAA Submission of Oral TYK2 Deucracitinib in Adults with Moderate to Severe Plaque Psoriasis 3Dec2021 FDA Accepts for Priority Review Luspatercept/Reblozyl Supplemental BLA in Adults with Non-Transfusion Dependent (NTD) Beta Thalassemia with 27Mar2022 PDUFA 15Dec2021 FDA Approves Orencia/Abatacept in Combination with a Calcineurin Inhibitor and Methotrexate for Prevention of Acute Graft versus Host Disease (aGvHD) 2022: 20Jan2022 Japan Approves First CAR-T Therapy in Multiple Myeloma, Abecma/Ide-cel 28Jan2022 CHMP Positive Recommendation for CAR-T Cell Therapy Breyanzi/Liso-cel in Relapsed/Refractory DLBCL, PMBCL and FL3B 17Feb2022 FDA Accepts for Priority Review BLA for Breyanzi/Liso-cel as Second Line Therapy for Relapsed and Refractory Large B-Cell Lymphoma (2L DLBCL) with PDUFA of 24Jun202225Feb2022 CHMP Positive Recommendation for Opdivo/Nivo as Adjuvant Treatment for Patients with Radically Resected, High Risk Muscle Invasive Urothelial Carcinoma (MI-UC) with Tumor Cell PD-L1 Expression of ≥1% 25Feb2022 CHMP Positive Recommendation for Opdivo/Nivo plus Yervoy/Ipi for First Line Treatment of Patients with Unresectable Advanced, Recurrent or Metatstatic Esophageal Squamous Cell Carcinoma (1L ESCC) with Tumor Cell PD-L1 Expression of ≥1% 25Feb2022 CHMP Postive Recommendation for Opdivo/Nivo plus Chemotherapy for First Line Treatment of Patients with Unresectable Advanced, Recurrent or Metatstatic Esophageal Squamous Cell Carcinoma (1L ESCC) with Tumor Cell PD-L1 Expression of ≥1% 28Feb2022 FDA Accepts for Prior Review Application for Opdivo/Nivo plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer (NSCLC) with 13Jul2022 PDUFA 4Mar2022 FDA Approves Opdivo/Nivo plus Chemotherapy as Neoadjuvant Therapy for Certain Patients with Resectable Non-Small Cell Lung Cancer (NSCLC) 18Mar2022 FDA Approves First LAG-3 -Blocking Antibody Combination, Opdualag, (Nivolumab and Relatlimab rmbw) as Treatment for Patients with Unresectable or Metastatic Melanoma 25Mar2022 FDA Revised Date for Priority Review Luspatercept/Reblozyl Supplemental BLA in Adults with Non-Transfusion Dependent (NTD) Beta Thalassemia due to Major Modification with 27Jun2022 PDUFA 25Mar2022 Japan's Ministry of Health, Labour and Welfare Accepts Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma 29Mar2022 EMA Validates BMY's Application for Opdivo/Nivo plus Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer (NSCLC) 5Apr2022 EU Approval for Opdivo/Nivo plus Yervoy/Ipi as First Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1% (1L ESCC) 5Apr2022 European Commission Approval for Opdivo/Nivo with Chemotherapy as First-Line Treatment for Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma with Tumor Cell PD-L1 Expression ≥ 1% (1L ESCC) 5Apr2022 EU Approval for Opdivo/Nivp as Adjuvant Treatment for Patients with Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma with Tumor Cell PD-L1 Expression ≥1% (HR MI-UC) 5Apr2022 EU Approval for CAR T Cell Therapy Breyanzi/Liso-cel for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma 28Apr2022 FDA Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III ObstructiveHypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptom 27May2022 FDA Approves Opdivo/Nivo+Chemotherapy and Opdivo/Nivo+Yervoy/IPI as First Line Treatments for Unresctable Advanced or Metastatic Esophageal Squamosu Cell Carcinoma 3Jun2022 BMY WIthdraws sBLA for Reblozyl/Luspatercept for Non-Transfusion Dependent (NTD) Beta Thalssemia 24Jun 2022 FDA Approves CAR T Cell Therapy Breyanzi®f.Liso-cel or Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy 22Jul2022 Positive CHMP Opinion Recommending Approval for LAG-3-Blocking Antibody Combination Opdualag (nivolumab and relatlimab) for Treatment of Patients with Unresectable or Metastatic Melanoma 9Sep2022 FDA Approves Sotyktu/Deucra Oral Treatment for Adults with Moderate-to-Severe Placque Psoriasis 16Sep2022 EU Approval for LAG-3-Blocking Antibody Combination Opdualag (Opdivo/Nivo + Relatlimab) for Treatment of Unresectable or Metastatic Melanoma with PD-L1Expression of <1 Percent 20Dec2022 Breyanzi/Liso-cel Approves as Relapsed or Refractory Large B-Cell Lymphoma Second Line Therapy (2L RR DLBCL) in Japan 2023: 27Jan2023 Positive CHMP Opinion of Reblozyl/Luspatercept for Patients with non-Transfusion Dependent Beta Thalassemia 27Jan2023 Positive CHMP Opinion of Sotyktu/Deucra for Adults with Moderate to Severe Plaque Psoriasis 28Feb2023 FDA assigns PDUFA Date 13Oct2023 for Opdivo/Nivolumab as Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma 3Mar2023 EU Approval for Reblozyl/Luspatercept for Patients with non-Transfusion Dependent Beta Thalassemia 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 2020: 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 2020-2023 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) 10Jun2021 Positive Topline Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi (lisocabtagene maraleucel) Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma 16Jul2021 Opdivo/Nivo + Yervoy/Ipi in 1L Squamous Cell Carcinoma of the Head and Neck (SCCHN) did not meet primary OS endpoint based on CheckMate-651 (Opdivo monotherapy is already approved based on OS benefit in recurrent or metastatic SCCHN after platinum-based therapy since 2016) 17Aug2021 EMA Validates Opdivo/Nivo + Yervoy/Ipi and Opdivo + Chemotherapy Applications as First Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma 8Oct2021 LATTICE-UC Phase II Deucra Oral TYK2 Did Not Meet Primary/Secondary Endpoints in Moderate to Severe Ulcerative Colitis (may be due to under-dosing; small Phase II with higher dose expected to read mid-2022) 8Nov2021 Neoadjuvant Opdivo/Nivo + Chemotherapy Significantly Improves Event Free Survival (EFS) in Patients with Resectable Non-Small Cell Lung Cancer (NSCLC) in Phase 3 CheckMate-816 Trial 2022: 16Feb2022 Phase III VALOR-HCM in Patients with Obstructive Hypertrophic Cardiomyopathy Eligible for Septal Reduction Therapy (SRT) Hits Primary and Key Secondary Endpoints 14Mar2022 Bempeg (NKTR)+Opdivo/Nivo (BMY) versus Opdivo/Nivo Phase III PIVOT-001 in Previously Untreated Unrectable or Metastastatic Melanoma Dails to Meet Preimary Endpoints of PFS and ORR 14Apr2022 Bempeg (NKTR)+Opdivo/Nivo (BMY) versus TKI in Phase III PIVOT-09 poor to intermediate risk 1L RCC and Phase II in 1L UC failed to meet required endpoints with all other Bempeg+Opdivo/Nivo trials discontinued. 26May2022 Phase II PILOT Study Using CAR-T Cell Therapy Breyanzi/Liso-Cel Shows Substantial Durable Responses inPatient with Relapsed and Refractory DLBCL after First-Line Therapy (used for sBLA in addiiton to TRANSFORM) 10Aug2022 Topline Results from Phase 3 KarMMa-3 Trial Showing Abecma (idecabtagene vicleucel) Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma 29Jul2022 CheckMate -914 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as Adjuvant Treatment of Localized Renal Cell Carcinoma did not meet PFS Primary Endpoint15Sep2022 Adjuvant Treatment with Opdivo/Nivo Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence Free Survival (RFS) in Stage IIB/C Melanoma in CheckMate-76K Trial 31Oct2022 Reblozyl/Luspatercept COMMANDS Phase III Trial in First Line Very Low/Low/Intermediate Risk Myelodysplastic Syndrome (1L MDS) Met Primary and Key Secondary Endpoints (PEP/SEP) 2023: 26Jan2023 TRANSCEND CLL-004 Trial of Breyanzi/Liso-cel Met Primary Endpoint (PEP) of Complete Response Rate (CR) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (RRCLL) A variety of immuno-oncology (I/O) Opdivo/Yervoy indications in both the metastatic and adjuvant settings. 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 Squam |
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