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FDA Approves Taiho Oncology's Lytgobi for FGFR2-Rearranged Bile Duct Cancer

NEW YORK – The US Food and Drug Administration on Friday granted accelerated approval to Taiho Oncology's FGFR2 inhibitor Lytgobi (futibatinib) for patients with advanced cholangiocarcinoma whose tumors harbor FGFR2 fusions or rearrangements.

The agency approved Lytgobi for patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma based on the results of the Phase I/II TAS-120-101 trial. That study involved around 100 patients with bile duct cancer who had their tumors assessed via next-generation sequencing and were found to harbor FGFR2 fusions or rearrangements.

Around 8,000 patients in the US are diagnosed with cholangiocarcinoma each year, and 20 percent of these patients have the intrahepatic form of the disease. Among those with intrahepatic bile duct cancer, FGFR2 gene rearrangements drive up to 16 percent of tumors.

In the TAS-120-101 trial, the overall response rate was 42 percent, and all 43 patients experienced partial responses. The median duration of response was 9.7 months.

Taiho's cholangiocarcinoma drug joins two other FDA-approved FGFR inhibitors, Incyte's Pemazyre (pemigatinib) and BridgeBio/Helsinn's Truseltiq (infigratinib).

"Lytgobi covalently binds to FGFR2 and inhibits the signaling pathway," Taiho said in a statement. "The other approved FGFR inhibitors are reversible [adenosine triphosphate]-competitive inhibitors."

Earlier this month, Relay Therapeutics also announced "remarkable responses" in a trial of its FGFR2 inhibitor, RLY-4008, for cholangiocarcinoma.