In a significant development for colorectal cancer treatment, Takeda has successfully obtained FDA approval for Fruzaqla, a VEGF inhibitor, as a third-line treatment for adults with metastatic colorectal cancer (mCRC). This approval comes five years after Hutchmed’s fruquintinib, the drug’s original form, was first approved in China, marking it as the first domestically developed drug for a major cancer type in the country.
Takeda acquired the rights to fruquintinib outside of China in January, paying Hutchmed $400 million upfront with an additional potential of $730 million in milestone payments. Fruzaqla is intended for patients who have undergone chemotherapy, anti-VEGF treatment, and, if medically appropriate, anti-EGFR therapy. This approval, which came three weeks ahead of its scheduled PDUFA date, makes Fruzaqla the only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC.
Stefanie Granado, Ph.D., Takeda’s U.S. oncology chief, highlighted the significance of this approval, noting the limited options previously available for this common cancer and the excitement of bringing a chemotherapy-free, targeted therapy option to patients.
This approval follows other recent advancements in mCRC treatment, including the FDA’s endorsement of Taiho and Servier’s Lonsurf in combination with bevacizumab. However, Fruzaqla’s primary advantage is its chemotherapy-free nature, offering patients a better quality of life during recovery.
Takeda’s entry into the colorectal cancer treatment market aligns with its broader strategy of focusing on solid tumors and complements its existing gastrointestinal portfolio. The company is also pursuing approval for Fruzaqla in Europe and Japan.