Gavreto

Withdrawn

This medicine's authorisation has been withdrawn

pralsetinib

Overview

On 24 October 2024, the European Commission withdrew the marketing authorisation for Gavreto (pralsetinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Blueprint Medicines (Netherlands) B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Gavreto was granted a conditional marketing authorisation in the EU on 18 November 2021 for the treatment of non-small cell lung cancer (NSCLC). 

The European Public Assessment Report (EPAR) for Gavreto is updated to indicate that the marketing authorisation is no longer valid.

Gavreto : EPAR - Medicine Overview

Reference Number: EMA/576914/2021

Gavreto : EPAR - Risk management plan

Product information

Gavreto : EPAR - Product Information

Gavreto : EPAR - All authorised presentations

Product details

• Name of medicine:
  Gavreto
• Active substance:
  pralsetinib
• International non-proprietary name (INN) or common name:
  pralsetinib
• Therapeutic area (MeSH):
  Carcinoma, Non-Small-Cell Lung
• Anatomical therapeutic chemical (ATC) code:
  L01EX23

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Authorisation details

• EMA product number:
  EMEA/H/C/005413
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  Blueprint Medicines (Netherlands) B.V.

  Gustav Mahlerplein 2; 1082MA Amsterdam; Netherlands

• Opinion adopted:
  16/09/2021
• Marketing authorisation issued:
  18/11/2021
• Withdrawal of marketing authorisation:
  24/10/2024
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Gavreto : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Gavreto : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/41191/2021

CHMP summary of positive opinion for Gavreto

AdoptedReference Number: Gavreto