Supplemental New Drug Application Submitted for Nubeqa in Prostate Cancer Subset

A supplemental new drug application has been submitted to the Food and Drug Administration (FDA) for Nubeqa (darolutamide) plus androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer.

“Simply put, our ambition is to help more patients with prostate cancer,” Christine Roth, Executive Vice President of Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer, said in a press release from Bayer, the drug’s manufacturer. “We … hope to expand the use of Nubeqa to more patients with the disease, regardless of chemotherapy use.”

In particular, Nubeqa is an oral androgen receptor inhibitor, which blocks activity of the androgen receptor, a protein that aids cancer growth. With the submission of a supplemental new drug application, the pharmaceutical company is requesting a change to the drug’s label so that it includes another indication. The application includes data for the agency to review to determine whether it may potentially approve the drug for the indication requested, according to the FDA’s website.

According to the release, the application submission for Nubeqa is based on findings from the phase 3 ARANOTE trialrecently presented at the 2024 ESMO Congress. Results from the trial demonstrated that Nubeqa plus androgen deprivation therapy (reduces the amount of testosterone in the body) significantly improved radiological progression-free survival (the time during and after treatment when a patient with cancer lives without the disease worsening) in patients with hormone-sensitive (still responds to hormone therapy) prostate cancer. Adding Nubeqa to androgen deprivation therapy reduced the risk for radiological progression or death by 46% with low safety risks.

Nubeqa is currently indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer in combination with docetaxel, and for those with non-metastatic castration-resistant prostate cancer.

“[Nubeqa, androgen deprivation therapy], plus docetaxel is already a standard of care for men with [metastatic hormone-sensitive prostate cancer], and ARASENS shows that [Nubeqa] plus [androgen deprivation therapy] plus docetaxel had a favorable efficacy and safety profile compared with [androgen deprivation therapy] plus docetaxel in these patients,” explained Dr. Fred Saad, professor and chairman of urology and director of genitourinary oncology at the University of Montreal Hospital Center in Canada, in his presentation at this year’s ESMO Congress. “ARANOTE was designed to evaluate the role of [Nubeqa plus androgen deprivation therapy] without docetaxel to hopefully provide a new treatment option for men with [metastatic hormone-sensitive prostate cancer].”

According to the release from Bayer, prostate cancer is the second-most common cancer occurring in men and the fifth most common cause of death from cancer in men worldwide. An estimated 1.4 million men were diagnosed with prostate cancer in 2020, which included nearly 300,000 patients in the United States.

Most men who receive a diagnosis have localized prostate cancer (confined to the prostate gland) and can typically be treated with curative surgery and radiotherapy, per the release. Once the disease metastasizes, men may be treated with androgen deprivation therapy. Treatment for metastatic hormone-sensitive prostate cancer often starts with hormone therapy like androgen deprivation therapy alone, androgen deprivation therapy plus an androgen receptor inhibitor, or a combination of androgen deprivation therapy and chemotherapy. The release noted that with that treatment approach, most men with metastatic hormone-sensitive prostate cancer will progress to castration-resistant prostate cancer (prostate cancer that continues to grow despite the reduction of testosterone to very low levels), a form of the disease with limited survival.

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