Specialty Pharma Journal Specialty, Precision & Technology
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the Phase 3 CheckMate -451 study did not meet its primary endpoint of overall survival (OS) with Opdivo (nivolumab) 1 mg/kg in combination with Yervoy (ipilimumab) 3 mg/kg versus placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer (SCLC) without disease …
Tag Archives: nivolumab
November, 2018
October, 2018
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15 October
Bristol-Myers Squibb’s Opdivo Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Relapsed Small Cell Lung Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of …
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11 October
Bristol-Myers Squibb and Compugen Partner to Evaluate Therapeutic Regimen in Advanced Solid Tumors
NEW YORK & HOLON, Israel–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Compugen (NASDAQ: CGEN) today announced the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab), in patients with advanced …
August, 2018
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17 August
FDA Grants Accelerated Approval to Bristol-Myers Squibb’s Opdivo for Treatment of Small Cell Lung Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1 Approval …
July, 2018
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11 July
Bristol-Myers Squibb’s Opdivo-Yervoy Combo Receives FDA Approval for Certain Patients with Metastatic Colorectal Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) …
June, 2018
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22 June
FDA Accepts sNDA for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line NSCLC in Patients with Tumor Mutational Burden ≥10 mut/Mb
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). …
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4 June
FDA Lifts Partial Clinical Hold on Late-Stage Opdivo-Based Combination Study in Multiple Myeloma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision …
April, 2018
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19 April
FDA Grants Priority Review to the sBLA for Opdivo in Previously Treated Patients with Small Cell Lung Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is …
January, 2018
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12 January
Rare Melanoma Type Highly Responsive to Immunotherapy
TAMPA, Fla. – Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult because these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of …
December, 2017
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21 December
FDA Approves Bristol-Myers’ Opdivo as Adjuvant Therapy in Melanoma Patients
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.1 The purpose of adjuvant therapy is to reduce the …