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
Related News:- Taiho’s Lonsurf (trifluridine/tipiracil) + Bevacizumab Receives EC’s Approval as 3L Treatment of Refractory Metastatic Colorectal Cancer
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