Bayer Submits Application for NUBEQA to USFDA and EMA

"For men with mHSPC, there remains a high need for new treatment options that can extend overall survival and delay the progression to CRPC," said Christine Roth, Member of the Executive Committee of Bayer's Pharmaceutical Division and Head of the Oncology SBU at Bayer. "Prostate cancer is a key area of focus at Bayer and the U.S. and EU submissions for NUBEQA in mHSPC represent a significant milestone in our commitment to developing treatments that support men with prostate cancer throughout the different stages of the disease."

Additional submissions in mHSPC are planned globally. NUBEQA is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC  as well as an ANZUP-led international co-operative group Phase III trial, evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence .

The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, placebo-controlled trial prospectively designed to compare the use of a second-generation androgen receptor inhibitor (NUBEQA) plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12-week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

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