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Takeda (NYSE:TAK) has received EU regulatory approval for Fruzaqla for the treatment of patients with metastatic colorectal cancer who have been previously treatmed with standard therapies and who have progressed while on or are intolerant of treatment with trifluridine-tipiracil or regorafenib.
The approval follows a positive opinion by an advisory panel of the European Medicines Agency. The FDA approved Fruzaqla in November 2023 for the treatment of patients with metastatic colorectal cancer who had been previously treated with oxaliplatin- and irinotecan-based regimens, according to Takeda.
Takeda holds the development and commercialization rights to the product for regions outside of mainland China, Hong Kong and Macau. The drug is marketed in China under the brand name Elunate by HUTCHMED (HCM) and Eli Lilly (LLY), according to HUTCHMED.