Tag Archives: ipilimumab

November, 2018

28 November
Bristol-Myers’ Phase 3 Study of Opdivo Plus Yervoy Fails to Meet Primary Endpoint as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

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 …
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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) …
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7 November
Opdivo and Yervoy Combo Increased Overall Survival Across PD-L1 Expression Levels in Advanced RCC

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today results from a new exploratory analysis of the phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus the standard of care, sunitinib, in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). In an exploratory analysis of PD-L1 expression …
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24 July
FDA Expands Approval of Yervoy to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: …
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25 January
FDA Expands Approval of BMS’ Opdivo in Combination with Yervoy for Certain Melanoma Patients

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.1 This indication is approved under accelerated approval based on progression-free …
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29 October
FDA Expands Approval of BMS’ Yervoy in Melanoma

PRINCETON, N.J., Oct 28, 2015 (BUSINESS WIRE) — Bristol-Myers Squibb Company BMY, +0.60% today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm …
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