Taiho Oncology and Taiho Pharmaceutical Receive the US FDA’s Approval of Lonsurf (trifluridine/tipiracil) for Adult with Metastatic Colorectal Cancer
Shots:
- The US FDA has approved Lonsurf as monotx. or in combination with bevacizumab for mCRC before treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, an anti-VEGF biological therapy & RAS wild-type
- The approval was based on the P-III trial (SUNLIGHT) evaluating Lonsurf + bevacizumab vs Lonsurf alone in a ratio (1:1) in 492 patients., showed an improvement in OS & PFS, m-OS (10.8 vs 7.5mos.) with 39% reduction in risk of death, m-PFS (5.6 vs 2.4mos.) with a 56% relative risk reduction of disease progression
- Median time to worsening of the ECOG performance status score from 0 or 1 to 2 or more (9.3 vs 6.3mos.), OS & PFS benefits were associated with maintenance of QoL from baseline to cycle 6 with no clinical changes in mean scores in any subdomains for EORTC QLQ-C30 and EuroQol EQ-5D-5L HRQOL questionnaires & had a manageable safety profile
Ref: PR Newswire | Image: Taiho
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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.
