Bayer Submits Application for NUBEQA to USFDA and EMA
Bayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration USFDA as well as the submission of a Variation Type II application to the European Medicines Agency for the oral androgen receptor inhibitor NUBEQA
Whippany: Bayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) as well as the submission of a Variation Type II application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor NUBEQA (darolutamide). Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
The submissions are supported by positive results from the investigational Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for NUBEQA plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.1
"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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