Approved by the US Food and Drug Administration fruquintinib (Furuzakura, Takeda) Treatment for certain metastatic adults colorectal cancer People who have experienced disease progression during or after previous treatment.
More specifically, this approval also extends to adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy, anti-VEGF therapy, and in some cases anti-EGFR therapy. be done.
in a company press releaseTakeda Pharmaceutical Co. said the drug is a “first.” targeted therapy It has been approved for over 10 years for metastatic colorectal cancer, regardless of biomarker status or previous treatment. ”
approval The dose of the oral anti-VEGFR tyrosine kinase inhibitor was based on the significant overall survival benefit demonstrated in a randomized, placebo-controlled phase 3 trial. fresco and fresco-2 A study of fully pretreated adults with metastatic colorectal cancer.
Patients in both trials were randomly assigned in a 2:1 ratio to receive the following treatments: Recommended dose Fruquintinib 5 mg orally once daily or placebo for the first 21 days of each 28-day cycle. Treatment and best supportive care were continued until disease progression or unacceptable toxicity.
Of the 416 patients evaluated in the FRESCO trial, those who received fruquintinib showed a significant improvement in median overall survival – 9.3 months vs. 6.6 months in the placebo cohort (hazard ratio) [HR], 0.65). Among her 691 patients in FRESCO-2, treatment with fruquintinib also resulted in a median overall survival benefit of 7.4 months vs. 4.8 months (HR, 0.66).
The most common side effects were: high blood pressurepalmar-plantar red blood cell dysesthesia, proteinuriadysphonia, abdominal pain, diarrheaasthenia, both occurred in at least 20% of patients.
“A non-oral chemotherapy option that prolongs survival despite treatment with prior therapies is critically needed for the treatment of metastatic colorectal cancer,” said Kathy Eng, M.D., Vanderbilt University Medical Center. “, Takeda said in a press release. “We look forward to bringing new solutions to the right patients.”
Sharon Wooster, MA is an award-winning medical journalist based in Birmingham, Alabama who writes for Medscape, MDedge, and other affiliate sites. Although she currently focuses on oncology, she also writes about a variety of other medical specialties and healthcare topics. Contact her at sworcester@mdedge.com or on Twitter. @SW_MedReporter.