Takeda...received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

Takeda...announced that the U.S. Food and Drug Administration (FDA) has approved FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy...

FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Hutchison China MediTech Limited...today announces that fruquintinib capsules have been granted approval for drug registration by the National Medical Products Administration of China...for the treatment of metastatic colorectal cancer...

Median overall survival was 7·4 months (95% CI 6·7–8·2) in the fruquintinib group versus 4·8 months (4·0–5·8) in the placebo group (hazard ratio 0·66, 95% CI 0·55–0·80; p<0·0001)….Fruquintinib treatment resulted in a significant and clinically meaningful benefit in overall survival compared with placebo in patients with refractory metastatic colorectal cancer.

Takeda...announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

691 pts were randomized (F: 461 vs P: 230) and 686 pts received study drug (F: 456 vs P: 230). Median treatment Cycles received (range) were 3 (1, 20) for F vs 2 (1, 13) for P...These results, along with improved OS and PFS and favorable toxicity profile, further support F as a potential new treatment option for patients with refractory mCRC.

Among Chinese patients with metastatic CRC who had tumor progression following at least 2 prior chemotherapy regimens, oral fruquintinib compared with placebo resulted in a statistically significant increase in overall survival.