Reviewing use limits for gastric cancer drugs by Merck, BMS, BeiGene

The FDA is convening a panel of external experts to evaluate the use of PD-1 inhibitors for the treatment of stomach and oesophageal cancers. The scheduled meeting on September 26 will see the agency's advisory panel deliberating on whether the use of immunotherapies from Merck & Co., Bristol Myers Squibb, and BeiGene should be restricted based on PD-L1 expression in tumors.

The focus of the review will be on Bristol Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab), Merck's Keytruda (pembrolizumab), and BeiGene's tislelizumab, which has two pending applications. The objective is to determine if these therapies should be limited to patients with advanced gastric and gastroesophageal junction adenocarcinoma, as well as oesophageal squamous cell carcinoma (ESCC).

Currently, most of these drugs are already approved for use in treating various cancers, except for BeiGene's tislelizumab, which is still awaiting approval on two counts.