FDA Approves NUBEQA® (darolutamide) Application for Metastatic Hormone-Sensitive Prostate Cancer

Bayer has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for NUBEQA® (darolutamide). This oral androgen receptor inhibitor (ARi) is proposed to be used in conjunction with androgen deprivation therapy (ADT) to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is currently approved for treating adult patients with mHSPC in combination with docetaxel and for those with non-metastatic castration-resistant prostate cancer (nmCRPC).

Christine Roth, Executive Vice President at Bayer, emphasized the company's commitment to addressing the various stages of prostate cancer through innovative treatments. The acceptance of the sNDA for NUBEQA plus ADT represents a significant step towards providing an additional treatment option for mHSPC patients. If approved, NUBEQA could be used with or without chemotherapy, broadening the treatment possibilities for physicians and patients alike. Bayer is working closely with the FDA to expedite the approval process.

The application is supported by positive results from the Phase III ARANOTE trial, which were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology. NUBEQA is being developed in partnership with Orion Corporation, a Finnish pharmaceutical company.

The ARANOTE trial was a randomized, double-blind, placebo-controlled Phase III study focusing on the efficacy and safety of NUBEQA combined with ADT in mHSPC patients. The trial included 669 patients who were randomly assigned to receive either 600mg of NUBEQA twice daily or a placebo, both in addition to ADT. The primary endpoint was radiological progression-free survival (rPFS), which measures the time from randomization to either the first documentation of radiological disease progression or death from any cause. Secondary endpoints included overall survival, time to first castration-resistant event, initiation of subsequent anti-cancer therapy, PSA progression, undetectable PSA rates, pain progression, and safety assessments.

NUBEQA functions by competitively inhibiting androgen binding, AR nuclear translocation, and AR-mediated transcription, thanks to its distinct chemical structure. Aside from the ARANOTE trial, NUBEQA is undergoing evaluation in various clinical trials, including the ARASTEP Phase III trial and the DASL-HiCaP trial conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. These studies are investigating NUBEQA in different stages of prostate cancer to determine its efficacy and safety.

Prostate cancer is a prevalent disease among men, being the second most common cancer and the fifth leading cause of cancer-related death worldwide. In 2020, about 1.4 million men were diagnosed with prostate cancer, with nearly 300,000 cases in the U.S., resulting in approximately 375,000 deaths globally. Most men are diagnosed with localized prostate cancer, which can be treated with surgery or radiotherapy. However, around 10% of men present with mHSPC at diagnosis. These patients typically begin treatment with hormone therapy, such as ADT, ARi combined with ADT, or a combination of docetaxel and ADT, but many eventually progress to castration-resistant prostate cancer (CRPC).

Bayer continues to prioritize innovative approaches in oncology, with a portfolio that includes six marketed products and several others in different stages of development. The company's mission is to advance science to improve lives, addressing major health challenges and driving sustainable development. In 2023, Bayer employed around 100,000 people and generated sales of 47.6 billion euros, with significant investment in research and development.

Overall, the acceptance of the sNDA for NUBEQA by the FDA is a promising development in the treatment landscape for metastatic hormone-sensitive prostate cancer, potentially offering new hope for patients with this challenging condition.