Takeda’s Fruzaqla Receives the US FDA’s Approval for the Treatment of Metastatic Colorectal Cancer
Shots:
- 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
Related News:- Takeda’s Adcetris (brentuximab vedotin) Receives EC’s Approval for Previously Untreated CD30+ Stage III Hodgkin Lymphoma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
