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 Trial Results

The FDA's decision to broaden Nubeqa's label comes three years after its initial approval for use in combination with androgen deprivation therapy (ADT) and docetaxel chemotherapy in mCSPC patients. The new approval allows for Nubeqa to be used with ADT alone, offering a treatment option for patients unable to tolerate chemotherapy.

The expansion is 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 trial, emphasized the drug's "powerful efficacy" and the importance of this approval in providing physicians with more treatment options for their patients.

Nubeqa's Market Performance and Future Prospects

Nubeqa has shown impressive market performance, achieving blockbuster status in 2024 with global sales of €1.52 billion ($1.65 billion), representing a 78% increase from the previous year. The drug's strong momentum continued into 2025, with first-quarter sales reaching €515 million ($574 million), putting it on track to generate over $2 billion this year.

Bayer is not resting on its laurels, as the company is currently conducting a phase 3 trial to evaluate Nubeqa's potential in non-metastatic hormone-sensitive prostate cancer patients 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.

Competitive Landscape and Bayer's Pharmaceutical Portfolio

Nubeqa faces competition from established androgen receptor inhibitors such as Pfizer and Astellas' Xtandi, which generated $5.4 billion in sales in 2024, and Johnson & Johnson's Erleada, which achieved $784 million in sales last year.

Despite this competitive environment, Nubeqa, along with Bayer's kidney disease treatment Kerendia, has been instrumental in driving growth for the company's pharmaceutical division. In the first quarter of 2025, Kerendia saw an 89% increase in sales to €161 million ($179 million), contributing to a surprising 4.4% revenue increase in Bayer's pharma sector.

Bayer CEO Bill Anderson highlighted that the growth from Nubeqa and Kerendia has more than offset the declining sales of the aging blood thinner Xarelto, which experienced a 31% drop to €633 million ($706 million) in the same period.

As Bayer continues to navigate the evolving pharmaceutical landscape, the expanded approval and strong performance of Nubeqa represent a significant opportunity for the company to strengthen its position in the oncology market and drive future growth.