FDA approves Fruzaqla for treatment of refractory metastatic colorectal cancer
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The FDA approved fruquintinib for certain adults with previously treated metastatic colorectal cancer.
The indication applies to use of the agent in adults who received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy an anti-VEGF therapy and — if RAS wild-type and medically appropriate — an anti-EGFR therapy.
Fruquintinib (Fruzaqla, Takeda Pharmaceuticals) is an oral tyrosine kinase inhibitor of VEGF receptors 1, 2 and 3 previously granted fast track designation and review by the FDA for the refractory metastatic colorectal cancer indication.
“Patients with metastatic disease are often fragile and fatigued — due to both their condition as well as the therapies they have been exposed to. An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer,” said Cathy Eng, MD, FACP, co-director of GI oncology at Vanderbilt University Medical Center, said in a Takeda-issued press release.
“Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized,” Eng added. “I look forward to being able to offer a new solution to appropriate patients.”
FDA based approval on results from two randomized phase 3 studies — FRESCO and FRESCO-2.
The placebo-controlled FRESCO study evaluated the safety and efficacy of fruquintinib among 416 adults in China with previously treated metastatic colorectal cancer who had disease progression during or after fluoropyrimidine-, oxaliplatin and irinotecan-based chemotherapy. The double-blind, placebo-controlled FRESCO-2 trial evaluated fruquintinib among 691 adults with previously treated metastatic colorectal cancer who experienced disease progression during or after prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy an anti-VEGF biological therapy an anti-EGFR biological therapy if RAS wild type, and at least one of trifluridine/tipiracil or regorafenib.
Researchers randomly assigned participants in both studies in a 2:1 ratio to receive either oral fruquintinib 5 mg once daily or placebo for the first 21 days of each 28-day cycle plus best supportive care. Study participants received therapy until disease progression or they experienced unacceptable toxicity.
Results from the FRESCO study showed median OS of 9.3 months (95% CI, 8.2-10.5) among those treated with fruquintinib compared with 6.6 months (95% CI, 5.9-8.1) among the placebo group (HR = 0.65; 95% CI, 0.51-0.83). Further results from FRESCO-2 showed median OS of 7.4 months (95% CI, 6.78.2) for those treated with fruquintinib compared with 4.8 months (95% CI, 4-5.8) in the placebo group (HR = 0.66; 95% CI, 0.55-0.8
The most common adverse events related to the use of fruquintinib in 20% or more of patients included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea and asthenia.
References:
- FDA approves fruquintinib in refractory metastatic colorectal cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancer. Published Nov. 8, 2023. Accessed Nov. 9, 2023.
- Takeda receives U.S. FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer (press release). Available at: https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Receives-US-FDA-Approval-of-FRUZAQLA-fruquintinib-for-Previously-Treated-Metastatic-Colorectal-Cancer/. Published Nov. 8, 2023. Accessed Nov. 9, 2023.
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