Takeda announced this Monday that the European Commission (EC) has approved its monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) that have been previously treated with available standard therapies.
“People with metastatic colorectal cancer face numerous difficulties, derived from both their disease and the adverse effects of therapies. Given the complex nature of the disease, it is essential to introduce innovative treatments with this oral agent without chemotherapy. I am looking forward to having this new therapeutic option aimed at these patients,” stated Josep Tabernero, director of the Vall d’Hebron Institute of Oncology (VHIO).
Fruzaqla (fruquintinib) is intended for patients who have already received other therapies, including chemotherapies based on fluoropyrimidine, oxaliplatin and irinotecan, anti-VEGF and anti-EGFR agents, who have progressed or are intolerant to treatment with trifluridine-tipiracil (TAS-102) or regorafenib. The decision comes after the Committee on Medicinal Products for Human Use (CHMP) issued a positive opinion on April 25, 2024 and the US Food and Drug Administration (FDA) approved on November 8, 2023 its use in adults with mCRC previously treated with oxaliplatin-based regimens and irinotecan.
Fruzaqla shows a manageable security profile
The approval is based on the overall trial results, phase 3 of Fresco-2. The study evaluated fruzaqla in combination with best supportive care (BSC) versus placebo plus BSC in previously treated mCRC patients. Fresco-2 met all of its primary efficacy objectives as well as key secondary objectives and demonstrated a Maintained benefit in patients treated with fruzaqla, regardless of the types of previous therapies they had received. The drug demonstrated a manageable safety profile during the study. The adverse reactions leading to treatment discontinuation occurred in 20 percent of patients treated with fruzaqla plus BSC, compared to 21 percent of those treated with placebo plus BSC. Fresco-2 data were published in The Lancet in June 2023.
“Today’s approval marks an important moment for the colorectal cancer community in the EU. For the first time in more than a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option which can be used regardless of whether your tumors harbor actionable mutations“said Teresa Bitetti, president of Takeda’s Global Oncology Business Unit. “We look forward to offering patients a novel treatment option that has a manageable security profile and that it can be effective regardless of the types of previous therapies they have received,” he added.
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