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30-01-2023 | EMA | News


EMA recommends new indication for darolutamide

Author: Shreeya Nanda


medwireNews: The EMA has recommended that the indication for darolutamide be expanded to include the treatment of metastatic hormone-sensitive prostate cancer (HSPC).

The androgen receptor inhibitor should be given in combination with docetaxel and androgen deprivation therapy (ADT) to adult patients, states the Committee for Medicinal Products for Human Use.

Darolutamide is already approved for patients with nonmetastatic castration-resistant prostate cancer (CRPC) at high risk for developing metastases in Europe, and in the USA for both nonmetastatic CRPC and metastatic HSPC.

The current EMA decision follows the positive findings of the phase 3 ARASENS trial, in which the overall survival of men with metastatic HSPC was significantly prolonged with the addition of darolutamide to docetaxel plus ADT.

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