FDA Is Speeding Up Review of Padcev-Keytruda Combo for Bladder Cancer


The Food and Drug Administration is speeding up the review and potential approval of Padcev plus Keytruda for certain patients with urothelial carcinoma, the most common form of bladder cancer.

The Food and Drug Administration (FDA) is currently expediting its review of a two-drug combination — Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) — for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for treatment with a cisplatin-based chemotherapy.

The FDA plans on making an approval decision for the drug duo by April 21, 2023, according to a press release issued by Seagen and Astellas, the manufacturers of Padcev, and Merck, the manufacturer of Keytruda.

Padcev plus Keytruda was initially granted a Breakthrough Therapy designation by the FDA in February 2020 after findings from the randomized phase 1b/2 EV-103 trial (also known as KEYNOTE-869).

Now, more recent findings from the trial continue to show promise, with 64.5% of patients experiencing tumor shrinkage while on the therapy, according to findings published last July.

“Urothelial cancer, the most common type of bladder cancer, is associated with poor survival in the advanced stage,” Dr. Marjorie Green, senior vice president and head of late-stage development at Seagen, said in the release. “The investigational results from our clinical development program support the combination of Padcev and Keytruda as a potential treatment for this patient population.”

Urothelial carcinoma is the most common type of bladder cancer, making up approximately 90% of cases. Cisplatin-based chemotherapy is a common frontline treatment option for this patient population, though not everyone is eligible for that type of therapy. Researchers are hoping that Padcev plus Keytruda can help fill that need.

“Despite advancements in treatment options, approximately half of advanced bladder cancer patients in the U.S. are ineligible for cisplatin-based chemotherapy, and these patients need new options,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer for Merck Research Laboratories, in a press release.

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