The FDA has approved Takeda’s Fruzaqla (fruquintinib), marking a significant advancement for patients with relapsed or refractory metastatic colorectal cancer (CRC). Fruzaqla offers a new treatment option for individuals who have exhausted previous therapy options.
This approval authorizes the use of Fruzaqla in adults with CRC who have undergone prior chemotherapy, received anti-VEGF medication, and if suitable, anti-EGFR therapy. What sets Fruzaqla apart is that it is the first targeted, chemotherapy-free therapy for metastatic CRC, approved by the FDA in over a decade. Importantly, this approval is irrespective of a patient’s biomarker status or prior treatment history.
Takeda acquired the rights to fruquintinib for ex-China regions from Hutchmed earlier this year in a deal valued at up to $1.1 billion, contingent on meeting development, regulatory, and sales milestones. In China, Fruquintinib, under the brand name Elunate, became the country’s first domestically developed therapy for a significant cancer type back in 2018. Takeda’s partnership with Eli Lilly facilitates its availability in China.
The journey to FDA approval began after the international FRESCO-2 trial demonstrated Fruzaqla’s effectiveness. The drug reduced the risk of death by 34% compared to a placebo in a population of heavily pretreated metastatic CRC patients, regardless of their biomarker status and when used alongside supportive care.
While the drug exhibited similar efficacy in the Chinese patient population in the FRESCO trial, the FDA typically requires data from U.S. patients before approving new drugs. These compelling results were described as “practice-changing” when presented at the ESMO congress last year, challenging established therapies for pretreated CRC, including Bayer’s Stivarga (regorafenib) and Taiho’s Lonsurf (tipiracil hydrochloride and trifluridine).
Stivarga received FDA approval for relapsed or refractory CRC in 2012, and Lonsurf got the green light three years later. Earlier this year, Taiho’s drug was also approved for use alongside the off-patent VEGF antibody bevacizumab for the same patient population targeted by Fruzaqla.
Fruzaqla not only offers an oral alternative to Lonsurf/bevacizumab but also eliminates the need for intravenous infusion of the antibody component. It is currently undergoing regulatory review in Europe, with a submission made to the EMA in June.
Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, highlighted the critical need for new treatments for metastatic colorectal cancer patients. Fruzaqla, with its potential to provide a significant survival advantage without compromising patients’ quality of life, represents a promising step forward in this regard.
Analysts have estimated that sales of fruquintinib outside China could reach up to $1 billion annually at its peak, signifying its substantial market potential.
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