The European Commission (EC) has approved fruquintinib as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with standard available therapies, including fluoropyrimidine-based chemotherapies, oxaliplatin and irinotecan, anti-Vegf agents and anti Egfr agents, and who have progressed or were intolerant to treatment with trifluridine-tipiracil or regorafenib. The decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of 25 April 2024. Fruquintinib is the first new target therapy approved in the EU for metastatic colorectal cancer in over a decade, Takeda informs in a statement .
The approval – we read – is based on the results of the international phase 3 Fresco-2 study which evaluated fruquintinib in addition to best supportive care (BSC) compared to placebo plus BSC in patients with previously treated mCRC. The study met all key primary and secondary efficacy endpoints and showed significant benefit among patients treated with fruquintinib, regardless of prior therapies received in the same study. Fruquintinib – which is a potent tyrosine kinase inhibitor that acts selectively on the three Vegf receptors (-1, -2 and -3) and on the consequent signaling pathways that regulate angiogenesis, thus limiting tumor growth – has also demonstrated a good safety profile. Data from the Fresco-2 study was published in ‘The Lancet’ in June 2023.
Metastatic colorectal cancer, according to the International Agency for Research on Cancer, is the third most common in the world and has been associated with more than 1.9 million new cases and 900 thousand deaths in 2022. According to the Aiom Report Airtum ‘The numbers of cancer in Italy’, in 2023 approximately 50,500 new diagnoses were estimated and there are 513,500 people living in Italy after a diagnosis of colorectal cancer. In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths. Although early-stage CRC can be surgically resected, the metastatic form remains a disease with an unmet clinical need with poor outcomes and limited treatment options.
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