Merck announced on Monday that the U.S. Food and Drug Administration has granted priority review to two supplemental Biologics License Applications (BLAs) seeking approval of KEYTRUDA and KEYTRUDA QLEX, when each drug is given in combination with Padcev. The proposed indication covers patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.
The FDA has assigned a target action date of August 17 for the two applications. Both filings are supported by results from the Phase 3 KEYNOTE-B15 clinical trial, which the company says demonstrated improved survival outcomes for the treated population.
Priority review is a regulatory designation applied to applications for therapies that may represent a significant improvement in the treatment of serious conditions. The designation shortens the FDA review timeline relative to a standard review, but it does not itself indicate a final approval decision.
Context and implications
Merck submitted supplemental BLAs for two formulations of its PD-1 therapy - KEYTRUDA and KEYTRUDA QLEX - each intended to be used alongside Padcev for muscle-invasive bladder cancer in patients who can receive cisplatin-based chemotherapy. The company relied on Phase 3 data from the KEYNOTE-B15 trial to support the efficacy claims, specifically citing improved survival outcomes reported in that study.
With the FDA's priority review designation in place, regulatory reviewers will evaluate the evidence on an accelerated schedule ahead of the August 17 target date. Until the agency reaches a decision, the ultimate regulatory status of the two supplemental applications remains unresolved.
What this means for markets and healthcare sectors
- Pharmaceutical and biotech sectors: Regulatory progress for oncology agents typically draws attention across these sectors due to potential commercial and clinical implications.
- Oncology therapeutics and clinical development: The Phase 3 KEYNOTE-B15 trial results are central to the filings and therefore to how the applications are assessed by regulators and stakeholders.
- Regulatory and payer communities: A priority review designation signals the FDA views the applications as potentially addressing a serious condition with meaningful benefit, which can influence downstream reimbursement and clinical adoption discussions if approved.
Key timeline
The FDA's target action date for the supplemental BLAs is August 17. Until that date, the agency's review will continue and no final regulatory determination has been made.