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
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