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      FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX for Bladder Cancer Treatment

      Merck has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) concerning its anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The applications also include KEYTRUDA QLEX™, which combines pembrolizumab with berahyaluronidase alfa-pmph. Both treatments are being evaluated in conjunction with Padcev® (enfortumab vedotin-ejfv) for patients diagnosed with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.

      The priority review designation is intended to expedite the regulatory process for therapies that may offer significant improvements in treatment options for serious conditions. This review will assess the efficacy and safety of the combinations in the specified patient population, potentially leading to quicker access for those in need of new treatment alternatives. Merck continues to advance its commitment to addressing unmet medical needs in oncology.

      © 2026 KLEA News. All Rights Reserved. This article is provided for informational purposes only. It is not offered or intended to be used as legal, tax, investment, financial, or other advice.

      Source: KLEA News

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