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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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Taiho Oncology

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

Shots:

  • The US FDA has accepted the sNDA of Lonsurf for priority review as monotx. or in combination with bevacizumab for adult patients with mCRC. The US FDA’s decision is expected in Aug 2023
  • The sNDA was based on the P-III trial (SUNLIGHT) evaluating trifluridine/tipiracil + bevacizumab vs trifluridine/tipiracil alone in a ratio (1:1) in 492 patients. The trial was conducted by Servier & Taiho Oncology
  • The results showed an improvement in OS & PFS, following disease progression or intolerance on two prior CT regimens, m-OS (10.8 vs 7.5mos.), 39% reduction in risk of death, m-PFS (5.6 vs 2.4mos.) indicating a 56% relative risk reduction of disease progression & showed a manageable safety profile

Ref: PRNewswire | Image: Taiho

Related News:- Taiho Oncology Publishes P-II Trial (FOENIX*-CCA2) Results of Futibatinib for Metastatic Intrahepatic Cholangiocarcinoma in NEJM

Click here to­ read the full press release 

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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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