The approval was based on the data from 2 P-III studies (FRESCO-2) & (FRESCO) trial evaluating the safety & efficacy of Fruzaqla vs PBO in patients (n=934 & 416) with previously treated mCRC. The approval was received prior to the planned PDUFA date of Nov 30, 2023, under priority review
The results from the (FRESCO-2) & (FRESCO) trial depicted a mOS of 7.4mos. vs 4.8mos. & 9.3mos. vs 6.6mos. whereas mPFS seen in the (FRESCO) trial was 3.7mos. vs 1.8mos. The results from the trials were published in “The Lancet” & ”JAMA”
Earlier the company received approvals for Fruzaqla, a selective oral VEGFR -1, -2 & -3 inhibitor, by the NMPA (Sep’18) & EMA (Jun’23) as a treatment option for mCRC & an application to the PMDA was submitted on Sep’23
Ref: Businesswire | Image: Takeda
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