Takeda Stakes $1.13 Billion on Rights to Fruquintinib for Advanced Refractory Colorectal Cancer

Takeda said Monday it will license fruquintinib, an oral inhibitor of vascular endothelial growth factor receptors (VEGFRs)-1, -2, and -3, for development and commercialization for subtypes of refractory metastatic colorectal cancer (CRC).

Under the agreement, Takeda will pay Hutchmed $400 million up front and up to $730 million in additional potential payments relating to regulatory, development, and commercial sales milestones, as well as royalties on worldwide net sales, with the exception of mainland China, Hong Kong, and Macau.

Regulatory submissions for fruquintinib, which was approved in China in 2018, are expected in Europe and Japan later this year. The FDA granted the drug fast track designation in 2020, and last month, Hutchmed began a rolling submission of a new drug application, which is planned to be completed in the first half of 2023.

In a phase 3 multiregional clinical trial of fruquintinib in refractory metastatic CRC presented last year at the European Society for Medical Oncology Congress, the drug met its primary end point of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.

According to a report, the trial also met its key secondary end point of progression-free survival (PFS). Patients treated with fruquintinib achieved a median OS of 7.4 months (95% CI, 6.7-8.2) vs 4.8 months (95% CI, 4.0-5.8) with placebo (HR, 0.662; 95% CI, 0.549-0.800; P < .001). Treatment with fruquintinib also resulted in a median PFS of 3.7 months (95% CI, 3.5-3.8) vs 1.8 months (95% CI, 1.8-1.9) with placebo (HR, 0.321; 95% CI, 0.267-0.386; P < .001).