Takeda gains European Commission approval for Fruzaqla

The European Commission (EC) has approved Fruzaqla (fruquintinib) from Japanese pharma major Takeda (TYO: 4502).

Fruzaqla is authorized as a monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the US Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023.