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EMA Recommends Granting a Marketing Authorisation for Fruquintinib

It is intended for the treatment of patients with previously treated metastatic colorectal cancer
13 May 2024
Targeted Therapy
Colon and Rectal Cancer

On 25 April 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product fruquintinib (Fruzaqla), intended for the treatment of patients with previously treated metastatic colorectal cancer (mCRC).

The applicant for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch.

Fruzaqla will be available as 1 and 5 mg hard capsules. The active substance of Fruzaqla is fruquintinib, an antineoplastic agent and vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (ATC code: L01EK04). Fruzaqla is a selective inhibitor of the tyrosine kinases VEGFR-1, 2 and 3, which antitumour effects result from the suppression of tumour angiogenesis.

The benefits of Fruzaqla are a reduction in the risk of death and an increased overall survival in patients with previously treated mCRC, compared to placebo.

The most common side effects with Fruzaqla are hypertension, anorexia, proteinuria, PPES, hypothyroidism, dysphonia, diarrhoea, and asthenia.

The full indication is:

FRUZAQLA as monotherapy is indicated for the treatment of adult patients with mCRC who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.

Fruzaqla treatment should be initiated by a physician experienced in the administration of anticancer therapy.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after 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.

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