FDA Accepts Bayer's Application for Label Expansion of Nubeqa [Yahoo! Finance]
BAYER AG S/ADR (BAYRY)
NASDAQ:AMEX Investor Relations:
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Source: Yahoo! Finance
The sNDA is seeking label expansion of Nubeqa in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Year to date, shares of Bayer have lost 44.9% against the industry's growth of 4.8%. Image Source: Zacks Investment Research Nubeqa is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation and AR-mediated transcription. The sNDA submitted is based on positive results from the late-stage ARANOTE study. Results showed that Nubeqa plus ADT significantly reduced the risk of progression or death in patients with metastatic mHSPC when compared to placebo plus ADT. We note that Nubeqa is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for those with non-metastatic castration-resistant prostate cancer (nmCRPC). A potential FDA approval of the sNDA will e
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