Bayer's Nubeqa Gains FDA Approval for Expanded Use in Prostate Cancer Treatment

Bayer has achieved a significant milestone in its oncology portfolio with the U.S. Food and Drug Administration (FDA) granting approval for the expanded use of Nubeqa (darolutamide) in metastatic castration-sensitive prostate cancer (mCSPC) patients. This latest development marks a crucial step towards Bayer's ambitious €3 billion peak sales estimate for the androgen receptor inhibitor.

FDA Approval Details and Clinical Data

The FDA has approved Nubeqa in combination with androgen deprivation therapy (ADT) for all mCSPC patients, regardless of their eligibility for chemotherapy. This expansion builds upon the drug's previous approval in 2022, which was limited to use alongside ADT and docetaxel chemotherapy.

The approval was based on the results of the phase 3 ARANOTE trial, which demonstrated Nubeqa's efficacy in extending the time before tumor progression or death. The study, involving 669 patients, showed that Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46% compared to ADT alone.

Dr. Fred Saad, M.D., of the University of Montreal Hospital Center and principal investigator of the ARANOTE trial, commented on the results, stating, "Today's approval further expands physicians' options for using Nubeqa with and without docetaxel in this setting, providing a potential new choice for patients."

Market Performance and Future Prospects

Nubeqa has been steadily gaining traction in the pharmaceutical market since its initial approval in 2019 for non-metastatic castration-resistant prostate cancer (nmCRPC). The drug achieved blockbuster status in 2024, with global sales reaching €1.52 billion ($1.65 billion), representing a 78% increase from the previous year.

The first quarter of 2025 has already seen Nubeqa generate €515 million ($574 million) in sales, putting it on track to surpass $2 billion for the year. This strong performance, coupled with the success of Bayer's kidney disease treatment Kerendia, has contributed to a surprising 4.4% increase in revenue for Bayer's pharmaceutical sector in Q1 2025.

Bayer is not resting on its laurels, however. The company is currently conducting a phase 3 trial to evaluate Nubeqa's potential in non-metastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence. This study, with an estimated primary completion date in early 2027, could further expand Nubeqa's reach in the prostate cancer treatment landscape.