MHRA Approves Takeda's Fruquintinib for Metastatic Colorectal Cancer

Takeda UK has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for fruquintinib (Fruzaqla) as a new therapeutic option for adults with metastatic colorectal cancer (CRC) who have not responded to prior treatments. Fruquintinib works by hindering the development of new blood vessels in tumors, which are crucial for supplying nutrients and oxygen, thereby inhibiting cancer growth.

The regulatory approval was supported by findings from two crucial studies, FRESCO-2 and FRESCO. The FRESCO-2 study involved 691 adult patients with metastatic CRC who had previously undergone treatment. These patients either showed disease progression following prior therapies or were not tolerant to standard treatments like chemotherapy, biologics, trifluridine/tipiracil (TAS-102), and/or regorafenib. The study's results demonstrated that patients treated with Fruzaqla had a median survival time of 7.4 months, compared to 4.8 months for those who received a placebo. Moreover, the fruquintinib group experienced a median of 3.7 months without disease progression, contrasting with 1.8 months for the placebo group.

Additionally, the FRESCO trial, which was conducted exclusively in China with 416 adult participants, showed similar trends. Patients treated with Fruzaqla in this study had a median survival of 9.3 months, significantly higher than the 6.6 months observed in the placebo group. The delay in disease progression in FRESCO also mirrored the results found in FRESCO-2.

The standard dosage for fruquintinib is set at 5mg once daily for a period of three weeks, followed by a one-week break, forming a complete treatment cycle. During the trials, common side effects reported included a reduction in blood platelets, which can lead to easy bruising or bleeding, joint pain, and decreased appetite.

Julian Beach, the interim executive director of MHRA healthcare quality and access, emphasized the agency’s commitment to patient safety and access to high-quality, safe, and effective medical products. Beach noted, "We’re assured that the appropriate regulatory standards for the approval of this medicine have been met. As with all products, we will keep its safety under close review."