Core Viewpoint - Bayer has received FDA acceptance for its supplemental new drug application (sNDA) for Nubeqa, aiming to expand its label for treating metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy [1][3]. Bayer's Drug Development Efforts - Nubeqa is an androgen receptor inhibitor that has shown positive results in the late-stage ARANOTE study, significantly reducing the risk of progression or death in patients with metastatic hormone-sensitive prostate cancer compared to placebo plus ADT [3][4]. - The current indication for Nubeqa includes treatment for adult patients with metastatic hormone-sensitive prostate cancer in combination with docetaxel and for non-metastatic castration-resistant prostate cancer [4]. - Bayer is conducting a broad development program for darolutamide, which includes the phase III ARASTEP trial and the collaborative phase III DASL-HiCaP trial for various stages of prostate cancer [5][6]. Financial Performance and Strategic Moves - Bayer's pharmaceutical portfolio is under pressure due to generic competition for Xarelto, prompting efforts to strengthen its offerings, with Nubeqa being a key drug that generated over €1 billion in sales in the first nine months of 2024 [7]. - Bayer has entered a collaboration with Cytokinetics for the development of aficamten in Japan and acquired marketing rights for acoramidis in Europe, with an NDA filed with the FDA and a target action date set for November 29, 2024 [8][9]. Regulatory Developments - Bayer has submitted a Marketing Authorization Application (MAA) to the EMA for elinzanetant, which seeks approval for treating moderate to severe vasomotor symptoms associated with menopause [10].
FDA Accepts Bayer's Application for Label Expansion of Nubeqa