Bayer has secured a significant milestone in the development of its prostate cancer portfolio, following the U.S. Food and Drug Administration's (FDA) approval to expand the use of its androgen receptor inhibitor Nubeqa (darolutamide). The updated label allows Nubeqa to be prescribed to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also referred to as metastatic hormone-sensitive prostate cancer (mHSPC).
This expansion enhances the therapeutic options for patients who are unable to tolerate chemotherapy. As Bayer noted, the new approval enables Nubeqa to be used in combination with androgen deprivation therapy (ADT) alone, without the necessity of docetaxel chemotherapy. "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's decision was based on the findings from Bayer's phase 3 ARANOTE clinical trial. The study involved 669 patients randomized in a 2:1 ratio to receive either Nubeqa (600 mg) with ADT or a placebo with ADT. Results demonstrated that Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, achieving its primary endpoint. "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."
Dr. Fred Saad, M.D., the study's principal investigator from the University of Montreal Hospital Center, praised the results. “Today's approval further expands physicians' options for using Nubeqa with and without docetaxel in this setting, providing a potential new choice for patients,” he said.
First approved in 2019 for use with ADT in treating non-metastatic castration-resistant prostate cancer (nmCRPC), Nubeqa has shown strong commercial performance. In 2023, the drug achieved global sales of €1.52 billion ($1.65 billion), a 78% increase year-over-year. With €515 million ($574 million) in first-quarter 2024 sales, Bayer anticipates Nubeqa could surpass $2 billion in revenue in 2025. "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."
Looking ahead, Bayer is conducting another phase 3 study to determine if Nubeqa can enhance treatment in non-metastatic hormone-sensitive prostate cancer patients at high risk of biochemical recurrence. This trial is expected to reach its primary completion milestone in early 2027.
In the competitive androgen receptor inhibitor market, Nubeqa is positioned against well-established therapies such as Xtandi, developed by Pfizer and Astellas, which reported $5.4 billion in sales for 2024, and Johnson & Johnson's Erleada, which earned $784 million last year. "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."
Alongside Nubeqa, Bayer's kidney disease drug Kerendia has also contributed to the company's growth. Kerendia saw an 89% increase in first-quarter sales, reaching €161 million ($179 million). These successes have offset revenue declines in Bayer's older blood thinner, Xarelto, which saw a 31% drop to €633 million ($706 million). Bayer CEO Bill Anderson acknowledged the company's shifting pharmaceutical strategy, stating, “These gains more than offset the declines we're seeing on Xarelto.”
