Taiho’s Lytgobi (futibatinib) Receives the US FDA’s Approval for the Treatment of Intrahepatic Cholangiocarcinoma
Shots:
- The US FDA has approved Lytgobi for adult patients with prior treated, unresectable, LA, or metastatic iCCA harboring FGFR2 gene fusions or other rearrangements. The therapy was discovered by Taiho Oncology's parent company Taiho Pharmaceutical
- The approval was based on the results from the primary analysis of the P-II (FOENIX*-CCA2) trial evaluating Lytgobi (20mg, qd) in 103 patients The trial met its 1EPs & showed with ORR of 42% as measured by independent central review, m-DoR was 9.7mos. with 72% of responses lasting 6mos., was effective & well-tolerated
- The therapy covalently binds to FGFR2 and inhibits the signaling pathway while the other approved FGFR inhibitors are reversible ATP-competitive inhibitors
Ref: PRNewswire | Image: Taiho
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