The agency will convene the Oncologic Drugs Advisory Committee Sept. 26 to evaluate the risk-benefit profile of combining ICIs like nivolumab and pembrolizumab with chemotherapy as first-line treatments, according to an FDA briefing.
Current approvals do not require PD-L1 testing, but emerging data suggests that PD-L1 expression may be a predictive biomarker for treatment efficacy. The committee will discuss whether to implement PD-L1-based patient selection criteria.
The FDA’s review follows concerns raised by recent studies indicating limited benefits in patients with low or absent PD-L1 expression.
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