Dr_Microbe
- A U.S. FDA panel of advisors will meet in late September to debate whether or not to restrict using immune checkpoint inhibitors to deal with gastric and gastroesophageal junction adenocarcinoma, in addition to esophageal squamous cell carcinoma.
- The Sept. 26 meeting of the Oncology Drugs Advisory Committee may have implications for Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and Bristol-Myers Squibb’s (NYSE:BMY) Yervoy (ipilimumab) and Opdivo (nivolumab).
- These drugs are accredited regardless of a affected person tumor’s programmed dying cell ligand-1 (PD-L1) expression. However, the company famous that this expression “seems to be a predictive biomarker of therapy efficacy.”
- The FDA is asking consultants to weigh whether or not PD-L1 expression is an acceptable predictive biomarker for affected person choice and whether or not present information is ample to assist limiting use of immune checkpoint inhibitors primarily based on that expression.
- The committee will even talk about two Biologics License Applications from Beigene (BGNE) for tislelizumab for gastric and esophageal cancer indications.
More on Bristol-Myers Squibb, Merck
Source: Seekingalpha