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 accepted no matter a affected person tumor’s programmed demise cell ligand-1 (PD-L1) expression. However, the company famous that this expression “seems to be a predictive biomarker of remedy efficacy.”
- The FDA is asking consultants to weigh whether or not PD-L1 expression is an applicable predictive biomarker for affected person choice and whether or not present information is satisfactory to help limiting use of immune checkpoint inhibitors based mostly on that expression.
- The committee may 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