LEVERKUSEN (dpa-AFX) - Bayer AG (BAYZF.PK) Thursday said that the Food and Drug Administration or FDA has accepted the company's supplemental new drug application (sNDA) for Nubeqa for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The sNDA is based on results from Phase 3 ARANOTE trial, which showed Nubeqa plus androgen deprivation therapy (ADT) significantly reduced the risk of progression or death in mHSPC patients when compared to placebo plus ADT. Further, no new safety signals were observed.
Nubeqa, in combination with docetaxel, is currently indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
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