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The FDA will review an application to consider potential approval of Nubeqa plus androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.
The Food and Drug Administration (FDA) accepted a supplemental new drug application for Nubeqa (darolutamide) plus androgen deprivation therapy to treat metastatic hormone-sensitive prostate cancer.
The application’s acceptance was announced in a press release from Bayer, the manufacturer of Nubeqa.
According to the FDA’s website, a supplemental new drug application is submitted by a pharmaceutical company requesting changes to an already approved drug such as the expansions of the approved indications.
Glossary:
Androgen deprivation therapy: treatment to block or suppress the action or production of male hormones.
Overall survival: the time from treatment assignment to the date of all-cause death.
Prostate-specific antigen: a protein produced by the prostate gland and found in blood. This level may be higher than normal in patients with prostate cancer.
“[This] acceptance of our [supplemental new drug application] for Nubeqa plus [androgen deprivation therapy] for the treatment of patients with [metastatic hormone-sensitive prostate cancer] brings us closer to adding an additional treatment option for Nubeqa to benefit those living with [metastatic hormone-sensitive prostate cancer],” Christine Roth, executive vice president, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer, said in the release. “If approved, this would expand the indication for Nubeqa in patients with [metastatic hormone-sensitive prostate cancer] to include Nubeqa both with and without chemotherapy, providing physicians and their patients with an additional Nubeqa treatment option in this setting.”
The supplemental new drug application was based on results from the phase 3 ARANOTE trial presented at the 2024 ESMO Congress in September. Findings from the trial demonstrated that compared with androgen deprivation therapy alone, the addition of Nubeqa reduced the risk of radiographical progression or death by 46% and demonstrated low safety risks.
“[Nubeqa] and [androgen deprivation therapy] significantly improved [radiographical progression-free survival] in patients with [metastatic hormone-sensitive prostate cancer], showed a benefit across all secondary endpoints, [and] had a favorable safety profile, confirming previous studies using [Nubeqa],” 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. “We believe that Nubeqa and [androgen deprivation therapy], without the need of docetaxel, could become an additional standard of care for [metastatic hormone-sensitive prostate cancer].”
According to the release. The ARANOTE trial is a phase 3 study assessing the safety and efficacy of Nubeqa plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer. In particular, 669 patients with metastatic hormone-sensitive prostate cancer were randomized to receive either 600 milligrams of Nubeqa twice per day or a matching placebo in addition to androgen deprivation therapy.
The main areas of interest for researchers conducting the ARANOTE trial, according to the release, included radiological progression-free survival, defined as the time from treatment assignment to the date of radiological disease progression or all-cause death. Other areas of focus included overall survival, time to initiation of subsequent anti-cancer therapy, time from treatment assignment to the date of first castration-resistant event, time to pain progression, time to prostate-specific antigen progression, safety and prostate-specific antigen undetectable rates.
As a result of the findings presented at the 2024 ESMO Congress, Bayer submitted a supplemental new drug application to the FDA for Nubeqa plus androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer.
Nubeqa was originally approved by the FDA in July 2019 for men with non-metastatic, castration-resistant prostate cancer. It was then approved by the FDA in August 2022 in combination with the chemotherapy docetaxel for the treatment of adults with metastatic hormone-sensitive prostate cancer.
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