FDA Approves Expanded Use For Bayer's Prostate Cancer Drug

The FDA approved Bayer AG's BAYRY supplemental marketing application for Nubeqa (darolutamide) with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC).
The approval is based on the results of Phase 3 ARASENS trial that demonstrated a reduction in the risk of death by 32% in Nubeqa plus androgen deprivation therapy and docetaxel compared to ADT and docetaxel.
Nubeqa plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.
The recommended darolutamide dose for mHSPC is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until unacceptable toxicity or disease progression.
Docetaxel, 75 mg/m2 intravenously, is administered every three weeks for up to 6 cycles. The first dose of docetaxel should be administered within six weeks after starting darolutamide treatment.
In 2019, the FDA approved Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC), receiving a concomitant gonadotropin-releasing hormone analog or analog had a bilateral orchiectomy.
Price Action: BAYRY shares closed lower by 7.09% at $13.63 on Friday.