Bayer Completes Cancer Drug Rolling NDA

Bayer says it has completed a rolling NDA submission to FDA for its investigational prostate cancer drug darolutamide. The company says the submission is based on data from a Phase 3 ARAMIS trial in men with non-metastatic castration-resistant prostate cancer. FDA has given darolutamide a fast track designation.

The company says ARAMIS is evaluating the safety and efficacy of oral darolutamide in patients with non-metastatic castration-resistant prostate cancer who are currently being treated with androgen deprivation therapy as standard of care and are not at high risk for developing metastatic disease. The trial’s primary endpoint is metastasis-free survival.

Darlolutamide is described as an investigational, non-steroidal androgen receptor antagonist with a chemical structure that binds to the receptor and exhibits antagonistic activity, thus inhibiting the receptor function and the growth of prostate cancer cells.