FDA Approves Padcev-Keytruda Combo for Advanced Bladder Cancer


The FDA approved the combination for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for treatment with cisplatin-based chemotherapy.

The Food and Drug Administration (FDA) granted an accelerated approval to Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer, who are ineligible for cisplatin-based chemotherapy.

“The accelerated approval for the combination of Padcev and (Keytruda) marks an important milestone for the approximately 8,000 to 9,000 patients in the United States with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” Dr. Ahsan Arozullah, senior vice president and head of oncology development for Astellas, said in a press release from the company that manufacturers Padcev. “This patient population now has an additional treatment option to treat advanced bladder cancer at first diagnosis of metastatic disease.”

This FDA approval was based on findings from the EV-103/KEYNOTE-869 study, according to a statement from the agency. Two groups of patients within this study were treated with both Padcev and Keytruda, while another group of patients was treated with the combination or with Padcev alone. Patients from all groups did not receive prior systemic therapy for their disease and were ineligible for cisplatin-based chemotherapy.

In total, 121 patients with locally advanced or metastatic urothelial carcinoma were treated with Padcev plus Keytruda.

The objective response rate, or the percentage of patients in the study with a partial or complete response to treatment, was 68%. This included 12% of patients with complete responses to treatment, which is the disappearance of all signs of cancer, although it does not mean that the cancer was cured, according to the National Cancer Institute.

The median duration of response for patients treated with both Padcev and Keytruda was 22 months and ranged from one month to 46 months, according to the FDA’s statement.

“Advanced-stage urothelial cancer is aggressive and associated with devastating outcomes,” said David R. Epstein, chief executive officer of Seagen, in the release. “In the EV-103 clinical trial, the use of Padcev in combination with (Keytruda) resulted in confirmed and durable tumor responses in over two-thirds of patients with advanced bladder cancer.”

The most common side effects related to treatment with Padcev and Keytruda, which occurred in at least 20% of patients in the study, included laboratory abnormalities such as increased aspartate aminotransferase, increased glucose, decreased hemoglobin, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium and decreased albumin. Other side effects that occurred include rash, fatigue, peripheral neuropathy, decreased appetite, pruritus, nausea, dysgeusia, urinary tract infection, dry eye and dizziness.

According to the release from Astellas and Seagen, the combination therapy of Padcev plus Keytruda was granted breakthrough therapy designation by the FDA in February 2020. In addition, it was granted priority review by the FDA in December 2022.

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