FDA Grants Full Approval to Merck's KEYTRUDA® for First-Line Treatment of Advanced Bladder Cancer in Patients Ineligible for Platinum Chemotherapy

MSD today announced that the U.S. FDA has approved a labeling update for the anti-PD-1 therapy Keytruda for the first-line treatment of advanced urothelial carcinoma (bladder cancer). The U.S. FDA has converted this indication from accelerated approval to full approval. Additionally, the indication has been revised to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for any platinum-containing chemotherapy.

Previously, Keytruda was indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), or patients who are ineligible for any platinum-containing chemotherapy (regardless of PD-L1 status). This indication was granted accelerated approval based on tumor response rate and duration of response.

The subsequent Phase 3 KEYNOTE-361 trial evaluated the efficacy of Keytruda as monotherapy or in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic urothelial carcinoma (mUC) eligible for platinum-containing chemotherapy. Compared with standard chemotherapy, Keytruda did not meet the prespecified dual primary endpoints of overall survival and progression-free survival.

This labeling update follows the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) meeting held earlier this year, which was part of an industry-wide evaluation of accelerated approvals with unmet postmarketing requirements. The committee voted 5-3 in favor of maintaining the accelerated approval for Keytruda in the first-line bladder cancer indication.

(Original text abridged)

References:

[1] FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer). Retrieved August 31, 2021, from https://www.businesswire.com/news/home/20210831005968/en

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