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).
Bristol-Myers Squibb Company (BMY) announced 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 this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
Bristol-Myers Squibb has revealed promising data from its ongoing Phase 3 study investigating the efficacy of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients whose cancers have a high tumour mutation burden (TMB), regardless of PD-L1 expression.
Five Prime Therapeutics, Inc. (FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, announced that a development milestone for cabiralizumab has been achieved, triggering a $25 million payment from Bristol-Myers Squibb Company (BMS) (BMY) under the license and collaboration agreement between the companies established in 2015. The milestone was triggered by initiation of a multi-arm Phase 2 clinical trial (NCT03336216), sponsored by Bristol-Myers Squibb Company, evaluating cabiralizumab and Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer. “Effective treatment for patients with pancreatic cancer remains a significant unmet need and is a cancer for which existing immunotherapies have not been successful to date,” said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. “We are encouraged by the preliminary data presented at SITC 2017 and are pleased to see this trial underway.” The Phase 2 trial is expected to enroll approximately 160 ...
Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.
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