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Taiho’s Lytgobi Faces Heavy Competition, But Sets Efficacy Bar For Now

 
• By Alaric DeArment

The FGFR inhibitor beats prior entrants on efficacy in cholangiocarcinoma, although Relay presented data at ESMO for its investigational RLY-4008 showing especially high efficacy and tolerability.

Taiho Oncology won approval for Lytgobi in intrahepatic cholangiocarcinoma • Source: Shutterstock

Otsuka Pharmaceutical Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd.’s newly approved FGFR inhibitor, Lytgobi (futibatinib), is going for a subset of a subset of patients with cholangiocarcinoma that represents a narrower population than its competitors, but could dominate that segment based on its better efficacy numbers. However, Relay Therapeutics, Inc.’s early-stage candidate, RLY-4008, has shown response rates that could pose an even greater competitive threat.

Otsuka’s Taiho Oncology division received accelerated approval on 30 September from the US Food and Drug Administration for Lytgobi in patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
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Executives On The Move: Pathos Procures CEO From AstraZeneca, New CEO For TME Pharma, And More

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