Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer

10 Nov 2023
www.pmlive.com
Drug ApprovalClinical ResultAccelerated ApprovalADC
Takeda’s Fruzaqla receives FDA approval for metastatic colorectal cancer
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Source: PMLiVE
Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC).
Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy.
The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients.
Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable safety profile” across the two studies.
More than 150,000 new cases of CRC will be diagnosed in the US this year, and about 70% of CRC patients will experience metastatic disease, whether at diagnosis or after treatment.
Teresa Bitetti, president of Takeda’s global oncology business unit, said: "There is a pressing need for new treatments for individuals with mCRC, who have had limited options and continue to face poor outcomes…Fruzaqla has the potential to offer a significant survival benefit to patients without negatively impacting their quality of life.”
The company said the data from FRESCO and FRESCO-2 also supported its EU marketing authorisation application for Fruzaqla, which was validated and accepted for review by the European Medicines Agency in June.
The US approval comes just a few weeks after Takeda announced that the European Medicines Agency’s human medicines committee had recommended Adcetris (brentuximab vedotin) as part of a combination treatment in adults with previously untreated CD30+ stage 3 Hodgkin lymphomaCD30+ stage 3 Hodgkin lymphoma.
The Committee for Medicinal Products for Human Use has specifically recommended that the antibody-drug conjugate, which is already approved in the EU for certain lymphoma patients, be used alongside doxorubicin, vinblastine and dacarbazine for this subset.
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