Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).

The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.

The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.

The result demonstrated Nubeqa’s “powerful efficacy,” according to the trial’s principal investigator Dr. Fred Saad, M.D., of the University of Montreal Hospital Center.

“Today’s approval further expands physicians’ options for using Nubeqa with and without docetaxel in this setting, providing a potential new choice for patients,” Saad added in a release.

Nubeqa was originally approved in 2019 in combination with ADT to treat patients with non-metastatic castration-resistant (nmCRPC) who are at risk of developing metastatic disease.

Last year, Nubeqa achieved blockbuster status for the first time with global sales of 1.52 billion euros ($1.65 billion), an increase of 78% from the prior year. With first-quarter sales of 515 million euros ($574 million), Nubeqa is on its way to generating more than $2 billion in 2025.

In addition to the two existing tumor settings, Bayer is running the phase 3 trial to evaluate if the addition of Nubeqa could improve upon ADT in non-metastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence. The study has an estimated primary completion date of early 2027.

Other androgen receptor inhibitors on the market are Pfizer and Astellas’ powerhouse Xtandi, which was approved 13 years ago and generated sales of $5.4 billion in 2024, as well as Johnson & Johnson’s Erleada, which reached the market in 2018 and achieved $784 million in sales last year.

With Nubeqa and kidney disease treatment Kerendia—which achieved an 89% increase in sales to 161 million euros ($179 million) in the first quarter—Bayer has a pair of fast-rising drugs that allowed its pharma sector to post a surprising 4.4% increase in revenue in Q1.

“These gains more than offset the declines we’re seeing on Xarelto,” Bayer CEO Bill Anderson said last month of the aging blood thinner, which saw its sales tumble by 31% to 633 million euros ($706 million).