Datroway

Opinion

EMA has issued an opinion on this medicine

datopotamab deruxtecan

Overview

On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Datroway, intended for the treatment of breast cancer. The applicant for this medicinal product is Daiichi Sankyo Europe GmbH.

Datroway will be available as a 100 mg powder for concentrate for solution for infusion. The active substance of Datroway is datopotamab deruxtecan, an antineoplastic agent (ATC code: L01FX35). Datopotomab deruxtecan is a monoclonal antibody-drug conjugate that binds to TROP2-expressing tumour cells and undergoes internalisation and intracellular cleavage. This results in the release of deruxtecan in target cells, which causes DNA damage and apoptotic cell death.

The benefit of Datroway is prolonged progression-free survival compared to chemotherapy, as shown in a phase 3 randomised open-label study in patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer, following one or two prior lines of systemic therapy.

The most common side effects are stomatitis, nausea, fatigue, alopecia, constipation, vomiting, dry eye, keratitis, anaemia, decreased appetite, increased aspartate transferase (AST), rash, diarrhoea, neutropenia and increased alanine aminotransferase (ALT).

The full indication is:

Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).

Datroway should be prescribed and supervised by physicians experienced in the use of cancer treatments.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Datroway

AdoptedReference Number: EMA/CHMP/28954/2025 Rev. 1

Product details

• Name of medicine:
  Datroway
• Active substance:
  datopotamab deruxtecan
• International non-proprietary name (INN) or common name:
  datopotamab deruxtecan
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01FX35
• EMA product number:
  EMEA/H/C/006547
• Marketing authorisation applicant:
  Daiichi Sankyo Europe GmbH
• Opinion adopted:
  30/01/2025
• Opinion status:
  Positive