FDA Approves Pembrolizumab For Locally Advanced, Metastatic Urothelial Carcinoma


The FDA has also converted the indication for pembrolizumab from an accelerated to a full, regular approval for patients with urothelial carcinoma.

Pembrolizumab (Keytruda; Merck) has been granted an updated indication for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for any platinum-containing chemotherapy.

This update applies for pembrolizumab’s indication in first-line advanced urothelial carcinoma. According to a press release, the FDA has also converted this indication from an accelerated approval to a full, regular approval.

Pembrolizumab is an anti-programmed death receptor-1 (PD-1) therapy that increases the immune system’s ability to detect and fight tumor cells. As a humanized monoclonal antibody, it blocks the interaction between PD-1 and its ligands, thereby activating T lymphocytes, which can affect both tumor cells and healthy cells.

Previously, pembrolizumab was indicated for the treatment of locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed programmed death-ligand 1 (PD-L1), or for patients who were ineligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved based on clinical trial findings of tumor response rate and duration of response.

The continued approval for this indication was contingent upon verification of clinical benefit in confirmatory trials, and the phase 3 KEYNOTE-361 trial did not meet its dual primary endpoints of overall survival or progression-free survival, according to the press release. The trial investigated pembrolizumab as monotherapy and in combination with chemotherapy.

“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, in the press release. “We are confident in the role Keytruda will continue to play for these patients who have few other treatment options and are working with urgency to advance studies to help more patients living with bladder and other types of cancer.”

In addition to this indication, pembrolizumab is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 1 year of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.


FDA Approves Updated Indication for Merck’s Keytruda (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer). News release. Merck; August 31, 2021. Accessed September 1, 2021. https://www.merck.com/news/fda-approves-updated-indication-for-mercks-keytruda-pembrolizumab-for-treatment-of-certain-patients-with-urothelial-carcinoma-bladder-cancer/

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