Talzenna - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

talazoparib

Opinion

On 9 November 2023, 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 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:¹

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 (see section 5.1). Patients with hormone receptor (HR)-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 metastatic castration-resistant prostate cancer (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 (SmPC), which will be published in the revised European public assessment report (EPAR), 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.

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¹New text in bold

CHMP post-authorisation summary of positive opinion for Talzenna (X-15-G)

AdoptedReference Number: EMA/CHMP/488483/2023

Key facts

• Name of medicine:
  Talzenna
• EMA product number:
  EMEA/H/C/004674
• Active substance:
  talazoparib
• International non-proprietary name (INN) or common name:
  talazoparib
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01XK04
• Marketing authorisation holder:
  Pfizer Europe MA EEIG
• Date of opinion:
  09/11/2023
• Status:
  Positive