The U.S. Food and Drug Administration has approved Merck’s Keytruda and Keytruda Qlex, each in combination with Padcev, to treat adults with muscle-invasive bladder cancer before and after surgery, Merck announced.
Under the approved regimen, the therapies may be administered as neoadjuvant treatment before cystectomy and continued as adjuvant treatment following the procedure.
The approvals establish the combinations as the first and only regimens pairing a PD-1 inhibitor with an antibody-drug conjugate for adults with muscle-invasive bladder cancer, regardless of their eligibility for cisplatin-based chemotherapy.
The FDA’s decision was supported by results from the Phase 3 KEYNOTE-B15 trial, conducted in collaboration with Pfizer and Astellas. The study enrolled 808 patients.
The approvals also expand an existing indication based on the Phase 3 KEYNOTE-905 trial. Merck’s Keytruda and Keytruda Qlex, in combination with Padcev, were previously approved in the U.S. for use before and after surgery in patients with muscle-invasive bladder cancer who were ineligible for cisplatin-based chemotherapy.
Dr. Matthew Galsky of the Icahn School of Medicine at Mount Sinai said the approvals represent a meaningful development because nearly half of patients experience disease recurrence after bladder removal surgery.
He added that the new regimens mark a shift from cisplatin-based chemotherapy, which has been recommended for eligible patients for more than two decades, and provide additional treatment options regardless of cisplatin eligibility.
