The FDA has approved Fruzaqla (fruquintinib) for the treatment of adult patients with previously treated metastatic colorectal cancer. The FDA approval based on findings from two phase 3 trials: FRESCO-2, which was conducted in cancer centers around the world, and FRESCO, which was conducted in China.1-7
About Fruzaqala
Fruzaqala is an orally administered vascular endothelial growth factor (VEGF) inhibitor – it prevents essential blood vessel formation that allows cancer cells to grow and reproduce and is also referred to as an “angiogenesis inhibitor”.
The FRESCO-2 clinical trial compared best supportive care with and without fruquintinib in 691 patients who had experienced disease progression following treatment with TAS-102 and/or Stivarga (regorafenib), both are used to treat advanced recurrent colon cancer. Patients whose disease is microsatellite instability-high (MSI-H) or DNA mismatch repair (dMMR) deficient must have also been treated with an immunotherapy agent if available and deemed appropriate, and those with BRAF-mutant tumors had to have a BRAF inhibitor.
A total of 691 patients were treated with fruquintinib at 5 mg daily in a 3-weeks-on/1-week-off schedule plus BSC or placebo plus BSC and directly compared. Among all patients treated with fruquintinib the median survival duration was 7.4 months compared to 4.8 months for those treated with placebo and no fruquininib.
Fruquintinib was found to be convenient, well tolerated, and delayed cancer progression while prolonging survival when compared to best supportive care alone in patients with advanced colon cancer. Additional trials are ongoing evaluating fruquintinib in combination with other drugs and earlier in the management of stage IV disease.
Learn more about colon cancer and the treatment of advanced colon cancer.
Connect With Others for Support and information
CancerConnect was the first social network created for people with colon cancer. Founded by oncologists to support colon cancer patients and their caregivers, over 40 million individuals have accessed CancerConnect programs since 1997. CancerConnect is used by leading cancer centers like Dana Farber, Roswell Park and The James at Ohio State to support their patients. Join the conversation, ask questions, share your experience, and learn how the best cancer centers are treating colon cancer from others. Share your experience, ask a question, or start a conversation by posting on CancerConnect.
References
- https://jamanetwork.com/journals/jama/fullarticle/2685988
- Dasari A, Lonardi S, Garcia-Carbonero R, et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. J Clin Oncol. 2023;41 (suppl 16):3604. doi:10.1200/JCO.2023.41.16_suppl.3604
- Takeda and HUTCHMED announce new drug application (NDA) for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review. News release. Takeda and HUTCHMED Limited. May 25, 2023. Accessed June 5, 2023.
- https://www.takeda.com/newsroom/press-releases/takeda-and-hutchmed-announce-new-drug-application-for-fruquintinib-for-treatment-of-previously-treated-metastatic-colorectal-cancer-granted-priority-review/
- Dasari NA, Lonardi S, Garcia-Carbonero R, et al. FRESCO-2: a global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022;33(suppl 7):S1391-S1392. doi:10.1016/j.annonc.2022.08.021
- Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer. Takeda. News release. November 8, 2023. Accessed November 8, 2023.
- Li J, Qin S, Xu R-H, et al. Effect of fruquintinib vs placebo on overall survival in patients with previously treated metastatic colorectal cancer: the FRES
