(Sharecast News) - Hutchmed China announced on Monday that its partner Takeda has received approval from the European Commission for 'Fruzaqla', or fruquintinib, as a monotherapy for adult patients with metastatic colorectal cancer (CRC).
The AIM-traded company said the approval was based on the positive results from the phase three 'FRESCO-2' trial, and marked the first novel targeted therapy for metastatic CRC in the European Union in over a decade.
It said the approval was for patients who had been previously treated with standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who had progressed on or were are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
The FRESCO-2 trial demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) with a manageable safety profile.
Colorectal cancer is the third most prevalent cancer worldwide, with significant incidence and mortality rates in Europe, the US and Japan.
Despite advancements in early-stage CRC treatments, metastatic CRC remained challenging with limited options.
Fruquintinib, an oral inhibitor of all three VEGF receptors, was designed to limit off-target kinase activity, ensuring high drug exposure and sustained target inhibition.
It had shown consistent benefits across multiple studies, and was being explored in combination with other anti-cancer therapies.
Takeda held the exclusive global licence for fruquintinib outside of mainland China, Hong Kong and Macau.
The drug received US approval in November last year, and is marketed under the brand name Fruzaqla.
In addition to the EU approval, a submission to the Japan Pharmaceuticals and Medical Devices Agency was currently under review.
In China, fruquintinib is marketed as 'Elunate', and was included in the China National Reimbursement Drug List.
Since its launch, over 80,000 CRC patients have been treated with fruquintinib in China.
"This is a significant milestone for Hutchmed, as it is the first product from our research and discovery engine to be approved in Europe, achieved through our partnership with Takeda to make this possible in such a short period of time," said chief executive and chief scientific officer Weiguo Su.
"This novel oncology medicine is currently improving the treatment outlook in the US and China, and we look forward to seeing its impact for patients across Europe."
At 1104 BST, shares in Hutchmed China were up 0.53% at 283.5p.
Reporting by Josh White for Sharecast.com.
Hutchmed (HCM)