Takeda secures FDA approval for colon cancer drug

09 Nov 2023
www.biopharmadive.com
Drug Approval
Dive Brief:
The Food and Drug Administration on Wednesday approved a new targeted therapy for metastatic colon cancer, granting an OK to Furzaqla from Takeda.
The drug is cleared for adults with previously treated metastatic colorectal cancer, regardless of what protein markers their tumors express. Takeda claims it’s the first drug that targets all three subtypes of an important cellular regulator known as VEGF.
Known scientifically as fruquintinib, Fruzaqla won its clearance several weeks ahead of the FDA’s target Nov. 30 decision date. It’s already approved for colon cancer in China, where it’s marketed as Elunate by original developer Hutchmed.
Dive Insight:
Takeda made a bet on Fruzaqla when it licensed the drug from Hutchmed for $400 million upfront in January. The deal was a step toward bolstering the pharmaceutical company’s oncology business as its top-selling multiple myeloma drug Velcade came under pressure from generic competition.
Fruquintinib won approval in China five years ago, drawing the interest and support of Eli Lilly, which partnered with Hutchmed to market the therapy there.
Takeda’s deal covers rights to the drug outside of China and promises as much as $730 million in additional payments if certain milestones are met. Takeda is also seeking approvals in Europe and Japan.
The FDA’s approval was based on two late-stage trials of Fruzaqla: a colon cancer study in China that enrolled just over 400 patients, and a larger multi-regional study that was run across 14 countries. Results from both showed a statistically significant increase in survival among Fruzaqla-treated patients compared to those given placebo.
Colorectal cancer is one of the most tumor types and the second leading cause of cancer-related deaths in the world, according to the World Health Organization. While early-stage colon cancer can be treated with surgery, metastatic disease has fewer treatment options.
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