Source: Pharmaceutical Technology
Takeda holds the licence for developing, marketing and manufacturing fruquintinib outside of mainland China, Hong Kong and Macau. Credit: Tada Images / Shutterstock. In April 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use.
The approval is based on data from the Phase III multi-regional FRESCO-2 trial assessing Fruzaqla along with best supportive care (BSC) versus placebo plus BSC. Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
The trial met all primary and key secondary efficacy endpoints with the treatment demonstrating benefit regardless of patients’ previous therapy types.
The oral inhibitor had a manageable safety profile with adverse reactions that led to discontinuation of treatment.
Takeda holds the sole global licence for developing, marketing and manufacturing fruquintinib outside mainland China, Hong Kong and Macau. A submission for Fruzaqla was made to the Japan Pharmaceuticals and Medical Devices Agency in September 2023. It was first approved by the China National Medical Products Administration in September 2018 and commercially launched in China in November of the same year under the brand name ELUNATE.
Takeda Global oncology business unit president Teresa Bitetti stated: “The approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumours harbour actionable mutations.”