Takeda’s Fruzaqla (fruquintinib) has been approved by the European Commission (EC) to treat adults with previously treated metastatic colorectal cancer (CRC).
Patients eligible for the VEGF inhibitor will have received available standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, and anti-VEGF and anti-EGFR agents, and will have progressed on or been intolerant to either trifluridine-tipiracil or regorafenib.
CRC, which begins in either the colon or rectum, was the second most common cancer in Europe in 2022, with approximately 538,000 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 EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage FRESCO-2 trial, which evaluated Fruzaqla 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 demonstrated consistent benefit among patients treated with Fruzaqla regardless of prior therapy type, Takeda said, adding that the drug demonstrated a manageable profile.
Teresa Bitetti, president of the global oncology business unit at Takeda, said the approvals marked “an important moment for the colorectal cancer community in the EU”.
“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,” she said.
Fruzaqla received approval from the US Food and Drug Administration (FDA) in November 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 latest authorisation for the therapy comes just two months after Takeda’s Entyvio (vedolizumab) was approved by the FDA for subcutaneous administration in adults with moderately to severely active Crohn’s disease.
The company also recently received FDA accelerated approval for the use of its kinase inhibitor Iclusig (ponatinib) in adults who are newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia.