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13-05-2020 | EMA | News

approvalsWatch

EMA supports hybrid cabazitaxel formulation for mCRPC

Author: Lynda Williams

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medwireNews: A hybrid formulation of cabazitaxel has been supported for use in European patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel chemotherapy.

Cabazitaxel Accord received a recommendation for marketing authorization from the EMA’s Committee for Medicinal Products for Human Use. The agent is now available as a 20 mg/mL concentrate for infusion, following studies demonstrating bioequivalence to reference cabazitaxel, which was approved in 2011 as a 1-hour infusion at a dose of 25 mg/m2.

Both cabazitaxel formulations are for use alongside prednisone or prednisolone.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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