FDA Expands Indication of Keytruda for Bladder Cancer Subtype

Keytruda is now indicated for the treatment of locally advanced or metastatic urothelial carcinoma, a type of bladder cancer, although an unmet need remains in the treatment of these patients.

The Food and Drug Administration (FDA) has updated the indication for Keytruda (pembrolizumab) to include the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for any platinum-containing chemotherapy.

In addition, the agency converted this specific indication from an accelerated approval to a full (or regular) approval, according to a release.

The anti-PD-1 therapy was previously indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who were ineligible for cisplatin-based chemotherapy, those whose tumors expressed PD-L1 or in patients ineligible for any platinum-containing chemotherapy regardless of their PD-L1 status. Anti-PD-1 therapy utilizes the body’s immune system to find and destroy cancer cells.

The approval of this indication was based on the duration of response and tumor response rate. In addition, the FDA’s Oncologic Drugs Advisory Committee met earlier this year, where members voted 5-3 in favor of the accelerated approval of Keytruda for the first-line treatment of bladder cancer.

“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 Dr. Scot Ebbinghaus, vice president of clinical research for Merck Research Laboratories, in the 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.”

Keytruda has previously been approved for the treatment of patients with locally advanced or metastatic urothelial cancer whose disease progressed during or after platinum-containing chemotherapy or within 12 months of adjuvant or neoadjuvant treatment with a platinum-containing chemotherapy, according to the release. The therapy is also approved to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who either declined or are ineligible for cystectomy.

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