The clearance of Fruzaqla is supported by the results from two Phase 3 trials, including the FRESCO-2 trial and the FRESCO trial in which Fruzaqla met the primary and key secondary efficacy endpoints
Takeda’s global hub in Cambridge, Massachusetts. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has received the US Food and Drug Administration (FDA) approval for Fruzaqla (fruquintinib) to treat certain adults with metastatic colorectal cancer (mCRC).
Fruzaqla is a selective and oral targeted inhibitor of VEGFR -1, -2 and -3. It was designed by China-based HUTCHMED and Takeda.
The FDA has cleared the drug for patients who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
Fruzaqla is said to be the first and only selective inhibitor of all three VEGF receptor kinases authorised in the US for mCRC that has had prior treatment regardless of the presence of biomarkers.
The approval was obtained under the Priority Review process over 20 days in advance of the Prescription Drug User Fee Act (PDUFA) date of 30 November 2023.
The clearance of Fruzaqla is supported by the results from two Phase 3 trials, including the multi-regional FRESCO-2 trial and the FRESCO trial conducted in China.
In patients with previously treated mCRC, the studies compared VEGFR inhibitor plus supportive care versus placebo plus best supportive care.
Among the 734 patients treated with Fruzaqla, both late-stage studies demonstrated consistent benefits and met their primary and key secondary efficacy endpoints.
The safety profiles remained the same in all the trials.
Takeda Global Oncology Business Unit president Teresa Bitetti said: “There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
“Fruzaqla is the first novel chemotherapy-free treatment option approved for patients in the US regardless of biomarker status in more than a decade.
“For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
Fruzaqla has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”
The findings from both trials also supported the European Union marketing authorisation application (MAA) for fruquintinib in June 2023.