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The FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting on September 26 to reevaluate the approvals of checkpoint inhibitors for advanced gastric, gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma.
The current labeling for approved checkpoint inhibitors in this indication reflects broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression.
Also Read: Merck Stops Lung Cancer Study For Keytruda Combo Due To Ineffective Results, Side Effects.
Cumulative data have shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity.
The focus will be on whether these approvals should be restricted based on tumors’ PD-L1 expression.
The review includes existing approvals for Bristol Myers Squibb Co’s (NYSE:BMY) Opdivo (nivolumab) and Yervoy (ipilimumab), Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab), and pending applications for BeiGene Inc’s (NASDAQ:BGNE) Tevimbra (tislelizumab).
FDA would like the Committee’s opinion on the following:
Earlier this year, the FDA approved BeiGene’s Tevimbra as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
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