Takeda’s fruquintinib has been recommended by the European Medicines Agency’s human medicines committee to treat adults with previously-treated metastatic colorectal cancer (CRC).
If granted marketing authorisation by the European Commission (EC), fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for this patient population.
CRC, which begins in either the colon or rectum, was the second most common cancer in Europe in 2020, with approximately 520,000 new cases of the disease diagnosed that year.
Although early-stage CRC can be surgically resected, Takeda outlined that metastatic CRC “remains an area of high unmet need with poor outcomes and limited treatment options”.
The Committee for Medicinal Products for Human Use’s (CHMP) recommendation was supported by positive results from the late-stage FRESCO-2 trial, which evaluated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously-treated metastatic CRC.
The study met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with fruquintinib regardless of prior therapy type, the company said, adding that the drug demonstrated a manageable profile.
Awny Farajallah, chief medical officer, oncology at Takeda, said: “People living with metastatic CRC in the EU currently have limited treatment options, which can lead to poor outcomes. With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new, oral, chemotherapy-free option that may provide a survival benefit.
“We look forward to the EC’s official decision in the near future as we work to redefine the treatment landscape and help address a significant unmet need for those affected by metastatic CRC.”
The positive opinion comes five months after fruquintinib was approved by the US Food and Drug Administration, under the brand name Fruzaqla, to treat adults with metastatic CRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy.
The US regulator’s decision made fruquintinib the first targeted treatment option approved in the US for metastatic CRC, regardless of biomarker status or prior therapies in more than a decade.