Introduction#
Merck has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two applications related to its cancer treatment, KEYTRUDA, in combination with Padcev. This review is specifically for patients with muscle-invasive bladder cancer who can receive cisplatin-based chemotherapy.
What is Priority Review?#
The FDA's priority review designation is given to drug applications that show potential for significant improvements in treating serious health conditions. This means that the FDA will expedite its review process, aiming to provide patients with faster access to new treatments.
Key Details of the Applications#
The applications submitted by Merck are for supplemental Biologics License Applications for KEYTRUDA and KEYTRUDA QLEX. The FDA has set a target action date of August 17 for these applications, indicating when a decision will be made regarding their approval.
Supporting Evidence#
The applications are backed by data from the Phase 3 KEYNOTE-B15 trial, which showed that the combination of KEYTRUDA and Padcev resulted in improved survival outcomes for patients. This evidence is crucial in demonstrating the effectiveness of the treatment in a clinical setting.