Japanese pharmaceutical company Takeda has received the European Commission (EC) approval for Fruzaqla (fruquintinib) to treat a type of metastatic colorectal cancer (mCRC).
Fruzaqla is a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3), which play a key role in blocking tumour angiogenesis.
It was developed and marketed in China by Hutchmed, and Takeda is licensed to further develop, market, and manufacture the drug outside Mainland China, Hong Kong and Macau.
Fruzaqla is indicated for the treatment of mCRC in adults who have been previously treated with standard therapies and are intolerant to treatment with trifluridine-tipiracil or regorafenib.
The EC approval follows the EU’s Committee for Medicinal Products for Human Use (CHMP) positive opinion on the regulatory approval of Fruzaqla in April 2024.
Vall d´Hebron Institute of Oncology (VHIO) director Josep Tabernero said: “People living with metastatic colorectal cancer face numerous difficulties, stemming both from their illness and the adverse effects of therapies.
“Given the complex nature of the disease, introducing innovative treatments such as fruquintinib – an oral, chemotherapy-free targeted agent – is essential. I am looking forward to having a new choice for appropriate patients.”
The EC approval is based on the results from the Phase 3 FRESCO-2 trial, which investigated Fruzaqla plus best supportive care (BSC) compared to placebo plus BSC in previously treated mCRC patients.
The Phase 3 study met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with Fruzaqla, regardless of the prior treatment types.
In the study, Fruzaqla showed a manageable safety profile with adverse reactions leading to treatment discontinuation observed in 20% of patients.
Fruzaqla received the US Food and Drug Administration (FDA) approval and was submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA), last year.
Takeda global oncology business unit president Teresa Bitetti said: “Today’s approval marks an important moment for the colorectal cancer community in the EU.
“For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumours harbour actionable mutations.
“We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received.”
