The FDA’s approval of Fruzaqla was based on its positive Phase III trials. Credit: Orawan Pattarawimonchai via Shutterstock.

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

Fruzaqla is an inhibitor of all three VEGF receptor kinases and is indicated for patients already treated with fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy, an anti-VEGF therapy and if medically appropriate, an anti-EGFR therapy.

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Fruquintinib was developed and marketed in China by Hong Kong-based Hutchmed in 2018. Takeda acquired its ex-China rights in January of this year for an upfront payment of $400m.

The approval of Fruzaqla is based on data from Phase III trials FRESCO-2 and FRESCO, the latter conducted in China alone.

In FRESCO-2, patients with refractory mCRC who received Fruzaqla showed a median overall survival (OS) rate of 7.4 months versus 4.8 months in the placebo group (hazard ratio/HR: .66).

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Grade three or higher adverse events occurred in 63% of patients in the treatment group versus 50% in the placebo.

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The results were consistent with the FRESCO trial where patients were treated with Fruzaqla after two prior lines of chemotherapy.

The median OS there was 9.3 months versus 6.6 months for placebo (HR: .65). The median progression-free survival also significantly increased at 3.7 months versus 1.8 months.

In the US, GlobalData epidemiologists estimate 143,000 people will be diagnosed with mCRC in 2023 at a 1.4% annual growth rate until 2031.

The chemotherapy-free Fruzaqla, marketed as Elunate in China by Eli Lilly, will compete with Taiho and Servier’s chemotherapy Lonsurf in combination with the targeted therapy bevacizumab.

GlobalData analysts forecast sales for Lonsurf to reach $633m by 2028.

Additional competition will come from Bayer’s kinase inhibitor Stivarga (regorafenib), which registered $645m in sales last year.

Takeda has applications in place for Fruzaqla’s approval in Europe and Japan and is investigating the drug in Phase II trials for endometrial and triple-negative breast cancer.

GlobalData analysts anticipate sales for Takeda’s Fruzaqla to reach $340m by 2028.