Key takeaways:

FDA granted approval to darolutamide for metastatic hormone-sensitive prostate cancer.

Randomized phase 3 trial results showed darolutamide significantly improved radiographic PFS.

Perspective from Bilal A. Siddiqui, MD

The FDA has approved darolutamide without chemotherapy for treatment of metastatic hormone-sensitive prostate cancer.

The FDA based its approval off results from the randomized phase 3 ARANOTE trial, which showed darolutamide (Nubeqa, Bayer), an androgen receptor inhibitor, plus androgen deprivation therapy (ADT) significantly improved radiographic PFS compared with placebo plus ADT.

Darolutamide had previously been approved as part of combination therapy with docetaxel.

“Clinical data from the ARANOTE trial supporting this new regimen showed that Nub

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