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.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.