Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

In 2018, Hutchmed’s fruquintinib became the first domestically developed drug for a major cancer type to be approved in China. Five years later, the FDA has signed off on the VEGF inhibitor for adults with metastatic colorectal cancer (mCRC) as a third-line treatment.

Takeda pushed fruquintinib over the FDA finish line after acquiring its rights outside of China in January. The Tokyo company paid Hutchmed $400 million up front, with the potential for $730 million in milestone payments.

It will be known commercially as Fruzaqla and is for patients who have had chemotherapy, an anti-VEGF treatment and—if medically appropriate—an anti-EGFR therapy. The nod came three weeks ahead of its scheduled PDUFA date, making Fruzaqla the only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC, Takeda said.

“This is the third most prevalent cancer in the U.S. and still there have been very limited options,” Stefanie Granado, Ph.D., Takeda’s U.S. oncology chief, said in an interview. “To be able to now bring them an option that is chemotherapy-free and is a targeted therapy is really exciting for us.”

After there were no U.S. advances in the indication for eight years, there have been two in a span of three months. In August, the FDA approved Taiho and Servier’s Lonsurf in combination with bevacizumab—which was originally developed by Roche as Avastin—to treat the same population.

Lonsurf, a chemotherapy which was originally endorsed in 2015, was found to be more effective when paired with bevacizumab, reducing the risk of death by 39%.

Approval of the combo shouldn’t affect the uptake of Fruzaqla since its primary selling point is that it is chemotherapy-free, providing patients with a better quality of life as they potentially recover.

“With Fruzaqla you can go to the park,” Granado said. “You have a treatment which is very efficient which will allow you to be there when your daughter gets to graduation, when your son gets married.”

Takeda also will compete with Bayer’s Stivarga, which reached the market in 2012. The kinase inhibitor, which also treats hepatocellular carcinoma and gastrointestinal stromal tumors, racked up sales of 613 million euros ($656 million) last year. Lonsurf, which also treats stomach cancer, pulled in $211 million in the U.S. in 2022.

Takeda bought into fruquintinib after Hutchmed revealed data from a global trial of nearly 700 heavily pretreated patients that showed it reduced the risk of death by 34% compared to placebo. At the time, Chi-Med’s international chief medical officer Marek Kania, M.D., called the results “practice changing.”

In China, where it is known as Elunate, Eli Lilly commercializes the treatment. Hutchmed recorded sales of $94 million for Elunate last year. Granado did not speculate on Fruzaqla’s sales potential in the U.S. Takeda also has applications for approval in the works in Europe and Japan.

“This is a fantastic fit for us,” Granado said. “We want to be present in the solid tumor space and we now have the opportunity to enter into the colorectal space. Takeda overall is a GI company with Entyvio. To be now complementing from an oncology perspective is also very much aligned with our strategy.”