On 9 November 2023, the European Medicines Agency’s (EMA’s) 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 talazoparib (Talzenna).
The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
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 (new indication in bold):
Breast cancer
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Prostate cancer
Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.
