The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for NUBEQA (darolutamide), potentially broadening its use for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Currently approved for mHSPC in combination with docetaxel, this new submission aims to extend NUBEQA’s indication for use alongside androgen deprivation therapy (ADT) alone. If approved, this change would offer physicians and patients more flexible options for treating advanced prostate cancer.

The sNDA is underpinned by findings from the Phase III ARANOTE trial, which demonstrated that NUBEQA combined with ADT significantly reduced the risk of disease progression or death compared to placebo plus ADT. Bayer highlighted that the trial observed no new safety concerns, strengthening confidence in the treatment’s safety profile.

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, noted that expanding NUBEQA’s indications could provide an important alternative for patients, particularly those seeking chemotherapy-free options. She underscored the company’s commitment to advancing care in prostate cancer, a disease that remains a significant health burden worldwide.

ARANOTE trial results emphasize clinical benefits

The ARANOTE trial was a pivotal, double-blind, placebo-controlled study that enrolled 669 patients with mHSPC. Participants were randomly assigned to receive either 600 mg of NUBEQA twice daily or a placebo, both in combination with ADT. The study’s primary endpoint was radiological progression-free survival (rPFS), measuring the time until disease progression or death.

Results showed that NUBEQA, when paired with ADT, substantially extended rPFS compared to placebo and ADT. Secondary endpoints included overall survival, progression to castration resistance, time to PSA progression, and other clinical milestones. The outcomes collectively reinforce NUBEQA’s potential to deliver meaningful benefits in advanced prostate cancer care.

Bayer presented these findings at the 2024 European Society for Medical Oncology (ESMO) Congress, with detailed results also published in The Journal of Clinical Oncology. The comprehensive data further highlight NUBEQA’s promise as a versatile therapy in various prostate cancer stages.

A broad research pipeline for prostate cancer treatment

NUBEQA is part of an extensive clinical development program targeting different stages of prostate cancer. Beyond ARANOTE, the drug is being evaluated in the ARASTEP Phase III trial, which focuses on patients with high-risk biochemical recurrence but no detectable metastatic disease. Additionally, the international DASL-HiCaP trial, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, is assessing NUBEQA as an adjuvant therapy for localised prostate cancer with a high likelihood of recurrence.

Developed jointly by Bayer and Finnish pharmaceutical company Orion Corporation, NUBEQA represents a significant stride in advancing treatment options for prostate cancer, particularly for patients seeking alternatives to chemotherapy or those at varying stages of disease progression.

The road ahead

The FDA’s decision on this sNDA could mark a major milestone for NUBEQA, expanding its application and providing patients with more treatment flexibility. With its established safety profile and strong clinical data, NUBEQA is positioned as a critical option for managing advanced prostate cancer. As Bayer continues to work closely with regulatory authorities, patients and clinicians alike await further developments.

  Bayer, NUBEQA, Orion Corporation, U.S. Food and Drug Administration