CHMP positive for Talzenna + Xtandi (talazoparib + enzalutamide) to treatmetastatic castration-resistant prostate cancer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Talzenna
The marketing authorisation holder for this medicinal product is Pfizer. The CHMP adopted a new indication for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adults for whom chemotherapy is not clinically indicated.
For information, the full indications for Talzenna will be as follows: Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
110 mins
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