OncLive's April Roundup of Key FDA Decisions in Oncology onclive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from onclive.com Daily Mail and Mail on Sunday newspapers.
In CheckMate -577, Opdivo
1
Approval expands the role of Opdivo in earlier stages of disease, with two indications in the adjuvant setting across three types of cancer
1
PRINCETON, NJ, USA I May 20, 2021 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Opdivo
® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
1 The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated
Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
Bristol Myers Squibb Presents New Research at ASCO and EHA 2021 Featuring Novel Approaches and Demonstrating Significant Progress to Improve Survival in Cancer and Blood Disorders
First Phase 3 data from the RELATIVITY-047 trial highlight clinical benefit of LAG-3 blocking antibody relatlimab the company’s third distinct checkpoint inhibitor in combination with nivolumab for patients with previously untreated unresectable or metastatic melanoma First disclosure of results from CheckMate -648 demonstrate Opdivo plus Yervoy and Opdivo plus chemotherapy’s potential to address unmet needs in …
First Phase 3 data from the RELATIVITY-047 trial highlight clinical benefit of LAG-3 blocking antibody relatlimab the company’s third distinct checkpoint inhibitor in combination with nivolumab for patients with previously untreated unresectable or metastatic melanoma