Bayer: new Nubeqa application filed in US
(CercleFinance.com) - Bayer has announced that it had filed a supplemental new drug application (sNDA) with the US FDA for Nubeqa in the treatment of hormone-sensitive metastatic prostate cancer (mHSPC).
The German pharmaceutical group says that it bases its application on the favorable results of a Phase III study recently presented at the European Society for Medical Oncology (ESMO) congress.
Nubeqa, developed in collaboration with the Finnish laboratory Orion, is currently approved in the US for the treatment of mHSPC in combination with docetaxel, a type of chemotherapy.
The product is also approved for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
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The German pharmaceutical group says that it bases its application on the favorable results of a Phase III study recently presented at the European Society for Medical Oncology (ESMO) congress.
Nubeqa, developed in collaboration with the Finnish laboratory Orion, is currently approved in the US for the treatment of mHSPC in combination with docetaxel, a type of chemotherapy.
The product is also approved for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
Copyright (c) 2024 CercleFinance.com. All rights reserved.