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With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer
Priority ReviewPhase 3Clinical ResultDrug ApprovalNDA
The FDA doled out the approval for Lonsurf and bevacizumab under the priority review pathway.
EighFDAears after an initial FDA apLonsurfin hebevacizumabeated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen.
Instead of a single-agent regFDAn, the FDA on Wednesday cleared colorectal cancerd Taiho OncologycizLonsurfr previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo.
The Lonsurf-bevacizumab cocktail provedFDA be more efficacious tLonsurfho’s drug alone. Compabevacizumabnsurf monotherapy, the nmetastatic colorectal cancer reduced the risk of death byanti-VEGF inhibitorVEGF group of patients bevacizumabviously received a maximuRochetwo Avastinhemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux.
The FDA doled out this approval under the priority review pathway. It comes as Lonsurf nears a clash wLonsurfeda and Hutchmed’s fruquintinib in colorectal cancer.
In aFDAoup of colorectal patients who have exhausted treatments, fruquintinib rLonsurfthe risk of death by 34% over placebo. Patfruquintinibt thcolorectal cancer lived a median 7.4 months. But fruquintinib achieved that overall survival number in the FRESCO-2 trial in a more heavily pretreated population; some patients had also tried Bayer’s Stivarga, Lonsurf or a PD-1 agent.
After Hutchmed released those data last fall, Takeda in January pfruquintinib million upfront and promised up to $730 million in potential milestoVEGFR inhibitorVEGFRo in-license fruquintinib outside of Chinafruquintinibthe drug is already approved under the brand name Elunate.BayerStivargaLonsurfPD-1 agentPD-1
The FDHutchmedso put fruquintinib’s applicatioTakedaolorectal cancer under priority review, having assigned the application a target decision date of Nov. 30.fruquintinib
BesiFDA colorectal cafruquintinibed is also gunningcolorectal canceromach cancer indication with a positive China phase 3 readout in the second-line setting. But that study likely won’t be able to support a U.S. approval given the FDA's stance on China-only studies.
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