BAYZF - Bayer granted FDA's priority review for label expansion of prostate cancer therapy

German conglomerate Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) announced on Tuesday that the U.S. Food and Drug Administration (FDA) granted the priority review and accepted its supplemental New Drug Application ((sNDA)) for prostate cancer therapy Nubeqa. With the sNDA, Bayer (OTCPK:BAYRY) has requested the FDA approve the androgen receptor inhibitor in combination with chemotherapy, docetaxel for the treatment of metastatic hormone-sensitive prostate cancer ((mHSPC)). Nubeqa identified as darolutamide in generic terms, is already approved in the U.S. for the treatment of non-metastatic castration-resistant prostate cancer. The review for label expansion is conducted under the Project Orbis initiative of the FDA’s Oncology Center of Excellence (OCE). The program is intended to allow participating global health authorities to handle the submission and review of cancer therapies simultaneously. In March, Bayer (OTCPK:BAYRY) asked Chinese regulators to allow the expanded use of Nubeqa with docetaxel in mHSPC.

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Bayer granted FDA’s priority review for label expansion of prostate cancer therapy