FDA approves fruquintinib for metastatic colorectal cancer

The FDA has approved fruquintinib (Fluzacra) for the treatment of adult patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, or anti-VEGF therapy. R.A.S. Wild-type, medically relevant anti-EGFR therapy.¹

This approval was based on results from the multiregional phase 3 FRESCO-2 trial (NCT04322539) and the Chinese phase 3 FRESCO trial (NCT02314819), both of which tested patients with a history of We evaluated fruquintinib in combination with care (BSC) and placebo plus BSC. Treated mCRC.

“Patients with metastatic disease are often frail and fatigued, both due to their condition and the treatments they have received. “However, there is a critical need for non-oral chemotherapy options that offer survival benefits,” Cathy Eng, MD, FACP, Vanderbilt University Medical Center, said in a news release. “Colorectal cancer is such a diverse disease that it is difficult to bring progress to patients whose cancer has spread. We look forward to bringing new solutions to the right patients.”

In the FRESCO-2 trial, the median overall survival (OS) for fruquintinib plus BSC was 7.4 months (95% CI, 6.7-8.2) compared with 4.8 months (95% CI) for the placebo group. CI, 4.0-5.8) (HR, 0.662; 95% CI, 0.549-0.800; P < .001).² The addition of fruquintinib also improved progression-free survival (PFS) compared to the control regimen, with medians of 3.7 months (95% CI, 3.5-3.8) and 1.8 months (95% CI, 1.8-1.9), respectively. ) (HR, 0.321; 95% CI, 0.267-0.386; P < .001).

In the FRESCO trial, median OS for fruquintinib and BSC was 9.3 months (95% CI, 8.2-10.5) versus 6.6 months (95% CI, 5.9-8.1) for placebo and BSC (HR, 0.65 ; 95% CI, 0.51-0.83; P < .001).³ Fruquintinib also improved PFS compared to placebo, with median PFS of 3.7 months (95% CI, 3.7-4.6) and 1.8 months (95% CI, 1.8-1.8), respectively (HR, 0.26; 95 % CI, 0.21-0.34); P < .001).

“New treatments are urgently needed for patients with metastatic colorectal cancer, who continue to face limited options and poor prognosis. Fluzakura is available in the United States for patients regardless of biomarker status. “For far too long, this is the first novel non-chemotherapy treatment option approved.” “Healthcare providers and patients have had limited options when choosing treatments for metastatic colorectal disease.” “Furuzakura has the potential to significantly improve survival rates without negatively impacting patients’ quality of life.”

In a news release, the FRESCO and FRESCO-2 findings also support the marketing authorization application for fruquintinib in the European Union, which was verified and accepted for review by the European Medicines Agency in June 2023. I also mentioned that. Furthermore, in September 2023, we will submit a drug application to the Pharmaceuticals and Medical Devices Agency.

References

1. Takeda receives US FDA approval for Fluzakura™ (fruquintinib) for previously treated metastatic colorectal cancer. Mr. Takeda. news release. November 8, 2023. Accessed November 8, 2023.
2. Dasari NA, Ronaldi S, Garcia-Carbonero R, et al. LBA25 FRESCO-2: An international phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Anne Onkor. 2022;33(Supplement 7):S1391-S1392. doi:10.1016/j.annonc.2022.08.021
3. Li J, Qin S, Xu RH Effect of fruquintinib versus placebo on overall survival in patients with previously treated metastatic colorectal cancer: the FRESCO randomized clinical trial. Japan Automobile Manufacturers Association. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855