FDA clears Bayer’s Nubeqa in earlier-stage prostate cancer
The American medicines regulator has approved Bayer’s (BAYN: DE) Nubeqa (darolutamide) for broader use in patients with metastatic castration-sensitive prostate cancer (mCSPC), marking a step forward for the drugmaker’s prostate cancer franchise.
The decision clears the androgen receptor inhibitor for use on its own in adults with mCSPC, building on an earlier approval that required it to be combined with chemotherapy drug docetaxel.
The new indication is based on Phase III trial data showing that Nubeqa combined with androgen deprivation therapy (ADT) delayed disease progression compared to placebo and ADT alone.
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