FDA to Speed Up Review of New Metastatic Colorectal Cancer Drug

The FDA is reviewing fruquintinib for the treatment of certain patients with metastatic colorectal cancer.

The Food and Drug Administration (FDA) granted a primary review for a New Drug Application (NDA) to fruquintinib for patients with previously treated metastatic colorectal cancer, according to Takeda and HUTCHMED, the pharmaceutical companies manufacturing the drug.

According to the FDA, a priority review is granted to promising new treatment regimens and in granting them, the agency is agreeing to work with the company to expedite the review and potential approval of drugs within six months. The FDA set a goal of making an approval decision on fruquintinib on or by Nov. 30, 2023.

“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” Dr. Awny Farajallah, head of global medical affairs oncology at Takeda, said in a company-issued press release. “There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”

The priority review for the NDA was granted based on findings from two phase 3 trials: FRESCO-2, which was conducted in cancer centers around the world, and FRESCO, which was conducted in China.

FRESCO-2 investigated fruquintinib plus best supportive care compared with placebo plus best supportive care in 691 patients with previously treated metastatic colorectal cancer. To be eligible for the trial, patients had to have experienced disease progression or be intolerant to TAS-102 and/or Stivarga (regorafenib). Patients whose disease is microsatellite instability-high (MSI-H) or DNA mismatch repair (dMMR) deficient must have also been treated with an immunotherapy agent if available and deemed appropriate, and those with BRAF-mutant tumors had to have a BRAF inhibitor.

The trial, whose results were presented at the European Society for Medical Oncology Congress in September 2022, met its main goals, as patients in the fruquintinib-containing group tended to have improved overall survival (time from treatment until death of any cause) and progression-free survival (time from treatment until disease worsens). Additionally, study findings showed that the drug tended to be well-tolerated.

READ MORE: Oral Fruquintinib Provides ‘Potential New Option’ With ‘Added Convenience’ for Patients With Relapsed/Refractory Colorectal Cancer

Fruquintinib is an oral drug that works by inhibiting vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. VEGF receptors are essential in blood vessel formation that allows cancer cells to grow and reproduce. If fruquintinib is approved, it will be the first and only highly selective inhibitor of VEGF receptors. The drug is highly selective and minimizes off-target toxicities (damage to other cells), helping to decrease side effects caused by the drugs, according to the press release.

“The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China. We are pleased to have Takeda as our partner furthering development and commercialization of fruquintinib outside of China,” Dr. Michael Shi, head of research and development and chief medical officer at HUTCHMED said in the release. “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally.”

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