Truqap

Opinion

EMA has issued an opinion on this medicine

capivasertib

Overview

On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Truqap, intended for the treatment of locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations.

The applicant for this medicinal product is AstraZeneca AB.

Truqap will be available as 160 and 200 mg film-coated tablets. The active substance of Truqap is capivasertib, an antineoplastic agent and other protein kinase inhibitor (ATC code: L01EX27). The serine/threonine kinase AKT is a pivotal node in the phosphatidylinositol 3-kinase (PI3K) signaling cascade regulating multiple cellular processes including cellular survival, proliferation, cell cycle, metabolism, gene transcription and cell migration. Capivasertib selectively inhibits all isoforms of AKT (AKT1, AKT2 and AKT3) hampering downstream proliferation signalling and thereby reducing the growth of tumour cells.

The benefit of Truqap in combination with fulvestrant is an improved progression-free survival (PFS) in patients with ER‑positive, HER2‑negative advanced breast cancer with one or more PIK3CA/AKT1/PTEN alterations following recurrence or progression on or after an endocrine-based therapy, when compared to fulvestrant and placebo. The most common side effects of Truqap are diarrhoea, rash, nausea, fatigue, vomiting, stomatitis, hyperglycaemia, headache and decreased appetite.

The full indication is:

Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen (see section 5.1).

In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist.

For men, administration of LHRH agonist according to current clinical practice standards should be considered.

Truqap 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 Truqap

AdoptedReference Number: EMA/151857/2024

Product details

• Name of medicine:
  Truqap
• Active substance:
  capivasertib
• International non-proprietary name (INN) or common name:
  capivasertib
• Therapeutic area (MeSH):
  Breast Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01EX27
• EMA product number:
  EMEA/H/C/006017
• Marketing authorisation applicant:
  AstraZeneca AB
• Opinion adopted:
  25/04/2024
• Opinion status:
  Positive