Dr_Microbe
- A U.S. FDA panel of advisors will meet in late September to debate whether or not to restrict the usage of 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 might have implications for Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and Bristol-Myers Squibb’s (NYSE:BMY) Yervoy (ipilimumab) and Opdivo (nivolumab).
- These drugs are authorised regardless of a affected person tumor’s programmed loss of life 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 specialists to weigh whether or not PD-L1 expression is an applicable predictive biomarker for affected person choice and whether or not present knowledge is sufficient to help proscribing use of immune checkpoint inhibitors based mostly on that expression.
- The committee will even focus on two Biologics License Applications from Beigene (BGNE) for tislelizumab for gastric and esophageal cancer indications.
More on Bristol-Myers Squibb, Merck
Source: Seekingalpha