Home Business Life Sciences and Bio Pharma Bayer’s Nubeqa FDA Appro...

Bayer’s Nubeqa FDA Approval Expands Prostate Cancer Treatment

Life Sciences and Bio Pharma

Business Honor
05 June, 2025

Bayer’s Nubeqa gains FDA approval for expanded prostate cancer use, boosting its blockbuster growth trajectory.

Bayer has made a significant advancement in the life sciences and biopharma sector with the FDA approval to expand the use of its androgen receptor inhibitor, Nubeqa, for all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). This approval marks a crucial milestone for Bayer as it moves closer to its ambitious €3 billion peak sales target for Nubeqa.

Originally approved in 2019 for non-metastatic castration-resistant prostate cancer (nmCRPC), Nubeqa was first authorized for use in combination with androgen deprivation therapy (ADT) and chemotherapy (docetaxel) in mCSPC patients. The latest FDA approval now makes it possible for Nubeqa to be administered in conjunction with ADT for chemotherapy-intolerant patients, expanding its clinical use and offering new treatments for prostate cancer patients.

The phase 3 ARANOTE trials demonstrated that Nubeqa, when combined with ADT, significantly improved radiographic progression-free survival (rPFS) compared to ADT alone. Treating 669 patients randomized 2:1, the trial demonstrated a 46% decrease in risk of disease progression or death. Trial principal investigator Dr. Fred Saad highlighted Nubeqa's robust efficacy and additional treatment options the approval represents for clinicians and patients.

Bayer's Nubeqa already is a blockbuster, with sales of €1.52 billion ($1.65 billion) globally in 2024, an increase of 78% from the prior year. The medication recorded first-quarter sales of €515 million ($574 million) and is on track to reach more than $2 billion in revenue by 2025.

Apart from its existing indications, Bayer is running another phase 3 trial on Nubeqa's efficacy in non-metastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence, with data due early in 2027.

Bayer's Kerendia kidney disease treatment saw strong sales growth, contributing to a 4.4% Q1 revenue increase, highlighting the company's shift towards growth and innovation in life sciences.