The FDA will hold an Oncologic Drugs Advisory Committee (ODAC) meeting on September 26 to reevaluate approvals of checkpoint inhibitors for advanced gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma.
Current labeling for approved checkpoint inhibitors in this indication reflects broad approvals intended to treat patient populations independent of programmed cell death ligand-1 (PD-L1) expression.
Also Read: Merck Halts Lung Cancer Study for Keytruda Combo Due to Ineffective Results and 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 the 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).
The FDA would like to hear the Committee’s views on the following:
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Suitability of PD-L1 expression as a predictive biomarker for patient selection in this patient population
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Different risk-benefit assessments in different subpopulations defined by PD-L1 expression.
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Adequacy of cumulative data to restrict immune checkpoint inhibitor approvals based on PD-L1 expression.
Earlier this year, the FDA approved BeiGene’s Tevimbra as a 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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This article Cancer Drugs From Merck, Bristol Myers, BeiGene Are In Question As FDA Committee Discusses Limiting PD-1 Drugs For Stomach Cancer originally appeared on Benzinga.com
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