Dr Marshall on the FDA Approval of Fruquintinib in mCRC

John Lindsay Marshall, MD, chief, Hematology and Oncology, professor, medicine and oncology, director, Otto J Ruesch Center for the Cure of Gastrointestinal Cancers, Lombardi Comprehensive Cancer Center, Georgetown University, discusses the significance of the FDA approval of fruquintinib (Fruzaqla) in patients with metastatic colorectal cancer (mCRC).

On November 8, 2023, the FDA approved fruquintinib for adult patients with mCRC who previously received treatment with chemotherapy. Those with RAS wild-type disease must also have received prior treatment with an EGFR inhibitor, if medically appropriate.

This regulatory decision was supported by findings from the phase 3 FRESCO-2 (NCT04322539) and FRESCO (NCT02314819) trials, which investigated the efficacy and safety of fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated mCRC. In the multiregional FRESCO-2 trial, treatment with fruquintinib plus BSC led to a median overall survival (OS) of 7.4 months (95% CI, 6.7-8.2) vs 4.8 months (95% CI, 4.0-5.8) with placebo plus BSC (HR, 0.662; 95% CI, 0.549-0.800; P < .001). Furthermore, patients in the fruquintinib arm achieved a median progression-free survival (PFS) of 3.7 months (95% CI, 3.5-3.8) vs 1.8 months (95% CI, 1.8-1.9) with placebo (HR, 0.321; 95% CI, 0.267-0.386; P < .001).

In the Chinese FRESCO trial, the combination of fruquintinib and BSC resulted in a median OS of 9.3 months (95% CI, 8.2-10.5) compared with 6.6 months (95% CI, 5.9-8.1) with placebo in combination with BSC (HR, 0.65; 95% CI, 0.51-0.83; P < .001). Moreover, fruquintinib led to a median PFS of 3.7 months (95% CI, 3.7-4.6) vs 1.8 months (95% CI, 1.8-1.8) with placebo (HR, 0.26; 95% CI, 0.21-0.34; P < .001).

In the past, several therapies have emerged for the management of mCRC, including trifluridine/tipiracil (Lonsurf) with and without bevacizumab (Avastin), as well as regorafenib (Stivarga), Marshall says. Joining these therapies in the treatment paradigm is the VEGF inhibitor fruquintinib, which significantly improved OS vs placebo, benefiting patients with metastatic disease, Marshall concludes.