German pharmaceutical firm Bayer has secured the US Food and Drug Administration (FDA) Priority Review for its darolutamide, in combination with docetaxel, to treat a type of prostate cancer.
The US FDA has accepted the company’s supplemental New Drug Application (sNDA) for the combination, to treat metastatic hormone-sensitive prostate cancer (mHSPC).
It has reviewed the sNDA under its Oncology Center of Excellence (OCE)’s Project Orbis initiative, which supports the submission and review of cancer treatments.
Darolutamide is an oral androgen receptor inhibitor (ARi), developed by the company in partnership with Orion Corp, and docetaxel is a cancer therapy developed by Sanofi-Aventis.
The company has recently filed applications with the European Medicine Agency (EMA), Japan’s Ministry of Health, Labor and Welfare (MHLW), and China’s Center of Drug Evaluation (CDE), with additional submissions worldwide.
Bayer pharmaceutical division executive committee member and oncology SBU head Christine Roth said: “Bayer remains dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease.
“Today’s sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for darolutamide in combination with docetaxel to benefit men with mHSPC.”
Bayer’s sNDA is supported by positive results from the Phase 3 ARASENS trial in a total of 1,306 newly diagnosed patients.
The Phase 3 study assessed the use of a second-generation oral Ari plus androgen deprivation therapy (ADT) and docetaxel compared to ADT plus docetaxel.
Overall survival (OS) is the primary endpoint of the study, and time to castration-resistant prostate cancer (CRPC), pain progression, first symptomatic skeletal event (SSE), and initiation of subsequent anticancer therapy include the secondary endpoints.
In the study, the combination of darolutamide plus ADT and docetaxel showed a statistically significant improvement in overall survival (OS), compared to ADT plus docetaxel.
Darolutamide is already approved in more than 60 markets around the world, including the US, the European Union (EU), Japan and China, under the brand name Nubeqa.
