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Taiho Oncology Europe GmbH and Taiho Pharmaceutical Receive EC’s Conditional Marketing Authorization for Lytgobi to Treat Cholangiocarcinoma

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Taiho Oncology Europe GmbH and Taiho Pharmaceutical Receive EC’s Conditional Marketing Authorization for Lytgobi to Treat Cholangiocarcinoma

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  • The EC has granted conditional marketing authorization for Lytgobi monotx. to treat adult patients with LA or metastatic CCA with an FGFR2 fusion or rearrangement that have progressed after one prior line of systemic therapy
  • The conditional marketing authorization was based on the (FOENIX-CCA2) open-label trial evaluating Lytgobi (20mg, qd) in 103 patients with unresectable, LA or metastatic intrahepatic CCA harboring FGFR2 gene rearrangements, incl. fusions
  • The results showed that patients treated with Lytgobi achieved an ORR of 42% as assessed by independent review and m-DoR (9.7mos.) while 72% of the responses lasted >6mos.

Ref: PRNewswire | Image: Taiho

Related News:- Taiho Oncology Reports the US FDA Acceptance of sNDA for Priority Review of Lonsurf (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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