Takeda Pharmaceutical is increasing its oncology portfolio by buying rights to a Hutchmed colorectal most cancers drug that’s already authorized in China and is starting its regulatory overview within the U.S.
Based on phrases introduced Monday, Takeda agreed to pay $400 million up entrance for rights to fruquintinib globally, apart from mainland China, Hong Kong, and Macau, the place Hong Kong-based Hutchmed retains rights. Hutchmed is eligible to obtain as much as $730 million in milestone funds, plus royalties from gross sales if Takeda efficiently commercializes the drug in different markets.
China’s medicine regulator authorized fruquintinib in 2018. The small molecule was designed to dam three vascular endothelial progress issue receptors (VEGF) that play a task within the formation of blood vessels that nourish tumors and help their progress.
Early-stage colorectal most cancers might be surgically eliminated. If surgical procedure doesn’t work or a affected person relapses, remedy choices embody some medicine, corresponding to chemotherapy and sure biologic drugs. Final week, the FDA authorized Seagen’s HER 2-blocking small molecule Tukysa together with Herceptin as a remedy for HER 2-positive colorectal most cancers that has progressed regardless of earlier remedy with chemotherapy.
Fruquintinib was examined in a Part 3 scientific trial—carried out within the U.S., Europe, Japan, and Australia—that enrolled 691 sufferers with superior colorectal most cancers. Outcomes confirmed that median general survival, the principle objective of the examine, was 7.4 months for these handled with the examine drug in comparison with 4.8 months within the placebo group. On the measure of progression-free survival, which is how lengthy sufferers lived with out their most cancers worsening, outcomes confirmed a median 3.7 months for the remedy group in comparison with 1.8 months within the placebo arm. These Part 3 outcomes have been introduced final September through the European Society for Medical Oncology assembly.
Final month, Hutchmed started a rolling submission for a brand new drug utility looking for FDA approval of fruquintinib. That utility is anticipated to be full within the first half of this yr. Regulatory submissions in Europe and Japan are additionally deliberate for later this yr.
“Fruquintinib has the potential to vary the remedy panorama for sufferers with refractory metastatic [colorectal cancer] who’re in want of further remedy choices,” stated Teresa Bitetti, president of the worldwide oncology enterprise unit at Takeda, stated in a ready assertion. “ We stay up for using our improvement and business capabilities to increase the potential of this progressive medication to sufferers past China.”
Public area picture by the Nationwide Most cancers Institute
