Bayer announced the U.S. FDA has approved Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer. Nubeqa was approved under the FDA Priority Review designation and approval was granted three months ahead of target FDA action date.
The FDA approval of Nubeqa was based on the phase 3 ARAMIS trial. The randomized, double-blind, placebo-controlled, multi-center study enrolled 1,509 patients with nmCRPC who were being treated with androgen deprivation therapy (ADT) and were at high risk for developing metastatic disease. The patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Data demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT. The most common adverse reactions in the darolutamide plus ADT arm were fatigue, pain in extremity and rash.
The U.S. FDA granted Fast Track designation for darolutamide in men with nmCRPC.
An MAA application is under review by the European Medicines Agency and the Ministry of Health, Labor and Welfare (MHLW) in Japan.
Darolutamide is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.
CRPC is an advanced form of the disease where the cancer keeps progressing despite ADT treatment, even when the amount of testosterone is reduced to very low levels in the body.
Darolutamide is an androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.