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: Yervoy
November, 2018
July, 2018
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19 July
Bristol-Myers Squibb and Gritstone Oncology Partner to Evaluate Novel Immunotherapy Approach in Advanced Solid Tumors
EMERYVILLE, Calif. & NEW YORK–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Gritstone Oncology today announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-based vector (prime) and a self-replicating …
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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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5 June
Opdivo Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy in Late-Stage Melanoma Trial
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of …
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1 June
Opdivo Plus Yervoy Improved Health-Related Quality of Life in Intermediate- and Poor-Risk Patients with Advanced Kidney Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced patient-reported outcomes data from the Phase 3 CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) treated with the Immuno-Oncology combination Opdivo (nivolumab) plus low-dose (1mg/kg) Yervoy (ipilimumab) versus sunitinib over a two-year follow-up period. Patients in the study treated with Opdivo plus low-dose Yervoy reported …
April, 2018
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16 April
FDA Approves Opdivo + Yervoy Combination as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).1,2 In the Phase 3 …
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16 April
Opdivo In Combination with Yervoy Reduces Risk of Progression or Death by 42% Versus Chemo in First-Line Lung Cancer Patients
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced initial results from the pivotal Phase 3 study, CheckMate -227, evaluating the Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab, 1 mg/kg) combination in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). In the study, the combination demonstrated …
January, 2018
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22 January
Opdivo in Combination with Yervoy Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced new data from a cohort of the phase 2 CheckMate -142 trial evaluating Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC). With a median of 13.4 months of follow-up, the primary …
December, 2017
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15 December
FDA Grants Priority Review to the sBLA for Opdivo Plus Yervoy for the Treatment of Advanced Renal Cell Carcinoma
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 priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for …