Takeda says FDA approves its treatment for colorectal cancer

By Stephen Nakrosis

Pharmaceutical company Takeda (JP:4502) said Wednesday that the U.S. Food and Drug Administration approved Fruzaqla as a treatment for certain patients with colorectal cancer.

Fruzaqla, or fruquintinib, an oral targeted therapy, was approved for adults with metastatic colorectal cancer who had received certain previous treatments for the condition.

The company said Fruzaqla and best supportive care showed "significant improvements in overall survival, with corresponding improvements in progression free survival, versus placebo plus best supportive care in two Phase 3 clinical trials."

Data from the trials supported an EU marketing authorization application for fruquintinib, "which was validated and accepted for review by the European Medicines Agency in June," Takeda said. A submission was made in September to the Japan Pharmaceuticals and Medical Devices Agency, the company said.

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11-08-23 1924ET

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