Yesterday, the FDA has approved a new oral medicine called Fruzaqla (fruquintinib) for the treatment of patients with previously treated metastatic bowel cancer.
Fruquintinib is a type of targeted therapy that blocks a protein called 'vascular endothelial growth factor receptor' (VEGFR).
It is the first chemotherapy-free treatment option to be approved for metastatic bowel cancer in more than a decade, according to Takeda, the drug’s manufacturer.
FDA approval follows two large Phase 3 trials, FRESCO and FRESCO-2, published in The Lancet and JAMA (Journal of the American Medical Association).
Participants took 5 mg of Fruzaqla orally once per day for the first 21 days of each 28-day cycle "until disease progression or unacceptable toxicity," the FDA stated.
In both trials, Fruzaqla showed "consistent benefit" and extended overall survival with a median overall survival (OS) of 9.3 months on Fruzaqla vs. 6.6 months placebo (FRESCO trial) and 7.4 months on Fruzaqla vs. 4.8 months placebo (FRESCO-2 trial).
