Bayer Prostate Cancer Drug Nubeqa gains third regulatory win from USFDA

With this approval, Nubeqa plus ADT is indicated in the U.S. for the treatment of adult patients with mHSPC, either with or without docetaxel. In addition, Nubeqa is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

“Clinical data from the ARANOTE trial showed that darolutamide is both efficacious and well tolerated as a combination therapy with androgen-deprivation therapy,” said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial. “Combined with the strong clinical efficacy demonstrated in the ARASENS trial (Nubeqa plus ADT and docetaxel), today’s approval further expands options for how physicians can use Nubeqa in the treatment of mHSPC, giving them greater flexibility in choosing treatment plans for their patients.”

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040.

“Patients with mHSPC want treatments that delay disease progression and extend life - without compromising their ability to stay active,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “This approval, supported by compelling clinical data, reaffirms Nubeqa’s potential to become a leading therapy across various stages of prostate cancer, underscoring our commitment to deliver meaningful outcomes for patients and their loved ones.”

Darolutamide under the brand name Nubeqa is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets around the world. It’s also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world. An approval process in the EU for the treatment of mHSPC in combination with ADT (without Docetaxel) is already underway.

Nubeqa achieved blockbuster status in September 2024, with annual sales reaching €1.52 billion for the full year of 2024.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti- cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in The Journal of Clinical Oncology showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The incidence of all adverse events (AE), including the incidence of serious and grade 3 and grade 4 AE, in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT.