Key View
- Takeda’s Fruzaqla will provide a new treatment option for metastatic colorectal cancer patients in the US following FDA approval.
- The approval of Fruzaqla will strengthen Takeda’s oncology pipeline and offerings, particularly with the recent withdrawal of Exkivity from global markets.
- We expect Fruzaqla will receive further market approvals in Europe and Japan, which will drive global sales.
Takeda’s Fruzaqla (fruquintinib) will provide a new treatment option for metastatic colorectal cancer (mCRC) patients in the US following FDA approval. On November 8 2023, Takeda received FDA approval for Fruzaqla (fruquintinib) as a third-line treatment in mCRC patients, meaning the drug can be used in patients who have previously received irinotecan-based chemotherapy, anti-VEGF therapy, and, if appropriate, an anti-EGFR therapy. Fruzaqla will therefore provide a new treatment option for colorectal cancer patients that have previously been treated with earlier therapies. The approval was based on positive data from Takeda’s Phase III FRESCO and FRESCO-2 trials, in which both studies met their primary and secondary efficacy endpoints. Fruzaqla will compete with Bayer’s Stivarga (regorafenib), which was approved by the FDA to treat mCRC in 2012. In August 2023, Servier and Taiho received FDA approval for Lonsurf in combination with bevacizumab for adult patients with mCRC, however a key advantage Fruzaqla has over Lonsurf is that it is a chemotherapy-free treatment. Demand for Fruzaqla will be supported by the high incidence rate of colorectal cancer in the US, with the National Cancer Institute estimating that more than 153,000 new cancer cases will be attributable to colorectal cancer in 2023, representing 7.8% of all new cancer cases in 2023.
The approval of Fruzaqla will strengthen Takeda’s oncology pipeline and offerings, particularly with the recent withdrawal of Exkivity (mobocertinib) from global markets. Exkivity received approval from the FDA in 2021 to treat adults with advanced stage lung cancer with mutations in the epidermal growth factor receptor. However, in October 2023, Takeda announced that it was working with the FDA to withdraw Exkivity from the US market. Takeda will also start a similar voluntary withdrawal process in global markets where Exkivity is currently approved. The withdrawal is due to a Phase III confirmatory trial that showed Exkivity failed to meet its primary endpoint, the confirmatory data requirements of the FDA’s accelerated approval and the conditional marketing approvals granted in other markets. Takeda’s oncology revenues have been impacted in recent years by generic competition to Velcade (bortezomind), which is indicated to treat multiple myeloma and mantle cell lymphoma. The approval of Fruzaqla will therefore offer Takeda another source of revenue in its oncology pipeline, with the company keen to develop its oncology offering, evidenced by several recent collaboration agreements.
