KEYTRUDA (pembrolizumab) or KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) + PADCEV (enfortumab vedotin-ejfv)
Perioperative treatment of muscle-invasive bladder cancer · Adults with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy and candidates for radical cystectomy
MRK · Merck
監管認定
完整時間線
7 個里程碑Original PDUFA date superseded by early approval
FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved the expanded perioperative indication on July 10, more than a month before the goal date.
Merck — Priority Review and original PDUFA date↗FDA approved perioperative treatment regardless of cisplatin eligibility
FDA approved KEYTRUDA or KEYTRUDA QLEX, each with PADCEV, as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with MIBC. The decision expanded the prior cisplatin-ineligible indication to all patients with MIBC who are candidates for cystectomy.
FDA — Approval of pembrolizumab and enfortumab vedotin for MIBC↗FDA granted Priority Review
FDA granted Priority Review to the KEYTRUDA and KEYTRUDA QLEX supplemental applications, each in combination with PADCEV, for cisplatin-eligible patients with MIBC and assigned the August 17 action date.
Merck — FDA granted Priority Review↗Detailed KEYNOTE-B15 results were presented
In cisplatin-eligible MIBC, perioperative KEYTRUDA plus PADCEV reduced the risk of recurrence, progression or death by 47% and the risk of death by 35% versus neoadjuvant gemcitabine and cisplatin followed by surgery. The Phase 3 trial also showed a higher pathological complete response rate.
Merck — Detailed Phase 3 KEYNOTE-B15 results↗相關新聞
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