EC Approves Takeda's Fruzaqla for Adult Metastatic Colorectal Cancer

Takeda’s Fruzaqla (fruquintinib) has received approval from the European Commission (EC) for the treatment of adults with previously treated metastatic colorectal cancer (CRC). This approval targets patients who have undergone standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, as well as anti-VEGF and anti-EGFR agents, and have progressed on or shown intolerance to either trifluridine-tipiracil or regorafenib.

Colorectal cancer, which originates in the colon or rectum, was the second most prevalent cancer in Europe in 2022, with approximately 538,000 new cases diagnosed that year. While early-stage CRC can often be removed surgically, metastatic CRC continues to present significant challenges, with poor outcomes and limited treatment options. Takeda emphasized that this remains a critical area of high unmet medical need.

The EC’s decision to approve Fruzaqla follows a recommendation from the European Medicines Agency’s human medicines committee. This recommendation was supported by positive results from the FRESCO-2 trial, a late-stage clinical study. The trial assessed the efficacy of Fruzaqla plus best supportive care (BSC) compared to a placebo plus BSC in patients with previously treated metastatic CRC. The study successfully met all its primary and key secondary efficacy endpoints, demonstrating consistent benefits for patients treated with Fruzaqla, regardless of their prior therapy types. Additionally, Takeda highlighted that Fruzaqla exhibited a manageable safety profile.

Teresa Bitetti, the president of Takeda's global oncology business unit, commented on the significance of the approvals, calling it “an important moment for the colorectal cancer community in the EU.” She expressed optimism about providing patients with a new treatment option that not only has a manageable safety profile but also remains effective regardless of the therapies patients have previously received.

Fruzaqla had already received approval from the US Food and Drug Administration (FDA) in November to treat adults with metastatic CRC who had previously undergone chemotherapy, an anti-VEGF therapy, and, in some cases, an anti-EGFR therapy. The approval by the EC comes just two months after another significant milestone for Takeda: the FDA approved Entyvio (vedolizumab) for subcutaneous administration in adults with moderately to severely active Crohn’s disease.

In addition to these advancements, Takeda recently secured accelerated FDA approval for its kinase inhibitor Iclusig (ponatinib) for use in adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia. These approvals mark a period of significant progress for Takeda in expanding their portfolio of treatments for various serious medical conditions.