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# Takeda Gets Approval for Fruzaqla
- URL: https://www.fdaweb.com/takeda-gets-approval-for-fruzaqla/
- Published: 2023-11-09T12:00:00.000Z
- Updated: 2026-09-14T14:15:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155757

FDA has approved a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in adult patients suffering from metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if medically appropriate and RAS wild-type, an anti-EGFR therapy.

Approval is based on data from two pivotal studies: FRESCO-2 (NCT04322539) and FRESCO (NCT02314819), according to an FDA [news release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancer?ref=fdaweb.com). FRESCO-*2* enrolled 691 patients with mCRC, and its results showed a median overall survival (OS) of 7.4 months for the fruquintinib group, compared to 4.8 months in the placebo group, it says. In FRESCO, 416 China-based patients were evaluated, and data showed median OS to be 9.3 months for the fruquintinib-treated patients, compared to 6.6 months for those on placebo.

FDA notes that the most common adverse reactions reported in these trials, occurring in more than 20% of patients, included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.