FDA Grants Priority Review for Padcev Plus Keytruda in Bladder Cancer

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The FDA has granted priority review for the Padcev-Keytruda combination in untreated patients with metastatic bladder cancer, according to a news release.

The Food and Drug Administration (FDA) has granted priority review for the supplemental Biologics License Application of Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) as a combination therapy for patients with metastatic urothelial cancer, according to a news release.

This is a first-line treatment combination that aims to treat patients with metastatic urothelial cancer, a form of bladder cancer that spreads to other organs and muscles in the body.

Padcev is a type of monoclonal antibody that binds to nectin-4, a protein that is found on some cancer cells. This anticancer drug is used to destroy cancer cells and may also help the patient’s immune system destroy cancer cells, according to the National Cancer Institute.

Keytruda is another type of monoclonal antibody and immune checkpoint inhibitor that binds to the protein PD-1, which helps immune cells effectively kill cancer cells, as defined by the National Cancer Institute.

According to the news release from Astellas Pharma, a co-manufacturer of Padcev, the FDA has set a target action date of May 9, 2024, under the Prescription Drug User Fee Act. The release also noted that this treatment combination would be the first treatment option available for patients who are either eligible or ineligible for treatment with cisplatin, a type of chemotherapy.

“Through our clinical development program, data have consistently shown the impact of combining (Padcev) with (Keytruda) for advanced bladder cancer. The FDA’s acceptance of our application is a critical step in our work as we seek to deliver this combination to more patients who currently have few treatment options at the advanced stage,” Dr. Roger Dansey, president of research and development for Seagan, a co-manufacturer of Padcev, said in the news release.

The supplemental Biologics License Application is currently being reviewed by the FDA under the program called real-time oncology review, which evaluates a productive review process to guarantee safe and effective treatments for patients in a timely manner, according to the news release.

This application for the respective first-line treatment combination is based on the findings from a phase 3 trial called EV-302 or KEYNOTE-A39.

Researchers from this study, the news release stated, determined that both progression-free survival (PFS; length of time during and after treatment when a patient lives with the disease without it worsening) and overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive) showed improved benefits for this previously untreated patient population when receiving the Padcev-Keytruda combination, compared with chemotherapy, the traditional treatment for this cancer type.

The FDA granted an accelerated approval to Padcev plus Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma and are ineligible for cisplantin-based chemotherapy earlier this year.

“We look forward to the FDA’s review of this application, which, if approved, will convert the accelerated approval of the combination based on results from the EV-103 study to standard approval for all first-line locally advanced or metastatic urothelial cancer patients, expanding the indication to cisplatin eligible patients,” Dr. Ahsan Arozullah, senior vice president and head of oncology development at Astellas Pharma, said in the news release. “These patients have a critical need for innovative new therapies, as chemotherapy has been the standard of care for over 30 years. We are committed to delivering on our goal of helping patients with advanced urothelial cancer live longer.”

The study also established consistent safety results with previous reports of safety for the treatment combination and did not find new safety issues, according to the news release.

However, some of the warnings for Padcev included — but were not limited to — serious skin reactions, high blood sugar and diabetic ketoacidosis, pneumonitis (inflammation in lung tissues), peripheral neuropathy (nerve damage near brain and spinal cord) and eye disorders.

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