FDA Approves Fruquintinib for Metastatic Colorectal Cancer

The US Food and Drug Administration has approved fruquintinib (Fruzaqla, Takeda) for the treatment of certain adults with metastatic colorectal cancer who experience disease progression during or after prior treatment.

More specifically, the approval extends to adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, in some cases, an anti-EGFR therapy.

In a company press release, Takeda Pharmaceuticals said the drug “is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade.”

Approval of the oral anti-VEGFR tyrosine kinase inhibitor was based on a significant overall survival benefit demonstrated in the randomized, placebo-controlled, phase 3 FRESCO and FRESCO-2 trials in heavily pretreated adults with metastatic colorectal cancer.

Patients in both trials were randomly assigned in a 2:1 ratio to receive the recommended dose of 5 mg of oral fruquintinib once daily or placebo for the first 21 days of each 28-day cycle. Treatment plus best supportive care continued until disease progression or unacceptable toxicity.

Among the 416 patients evaluated in the FRESCO trial, those who received fruquintinib demonstrated a significant improvement in median overall survival — 9.3 vs 6.6 months in the placebo cohort (hazard ratio [HR], 0.65). Among the 691 patients in FRESCO-2, treatment with fruquintinib also resulted in a median overall survival benefit — 7.4 vs 4.8 months (HR, 0.66).

The most common adverse reactions were hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia, which each occurred in at least 20% of patients.

“An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer,” Cathy Eng, MD, of Vanderbilt University Medical Center, stated in the Takeda press release. “I look forward to being able to offer a new solution to appropriate patients.”

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on Twitter: @SW_MedReporter.

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