Bayer Submits Application for Label Expansion of Prostate Cancer Drug

Bayer (BAYRY) announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide. The sNDA is seeking approval of darolutamide, in combination with androgen deprivation therapy (ADT), in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the androgen receptor with high affinity and exhibits strong antagonistic activity. It inhibits the receptor function ...