The Food and Drug Administration (FDA) has approved Fluzakura (fruquintinib) for the treatment of some adults with metastatic colorectal cancer (mCRC), biopharmaceutical company Takeda Pharmaceutical announced in a news release.
Patients are eligible for treatment with Fluzacra, an oral targeted therapy, after treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy and anti-VEGF therapy. Patients with wild-type RAS disease may also receive anti-VEGF therapy if medically appropriate. -EGFR therapy.
“There is an urgent need for new treatments for patients with metastatic colorectal cancer, who continue to face limited options and poor prognosis.” “This is the first new non-chemotherapy treatment option approved in more than a decade,” Teresa Vitetti, president of Takeda’s global oncology business, said in a news release. “For too long, healthcare providers and patients have had limited options when choosing treatments for metastatic colorectal cancer.” It has the potential to bring significant benefits to the
This approval was based on data from the Phase 3 studies FRESCO-2 and FRESCO, which lancet and Japan Automobile Manufacturers AssociationEach.
FRESCO-2 found that median overall survival (the length of time a patient lives after treatment) for patients treated with Fluzakura was 7.4 months, compared to 4.8 months for those treated with a placebo. did. Severe or severe side effects occurred in 63% of patients treated with Furuzakura and half of patients treated with placebo, with the most common side effects in the Furuzakura group including high blood pressure, asthenia (feeling weak or lethargic) ), hand-foot syndrome, etc. . In addition, one treatment-related death occurred in each group due to intestinal perforation in the Fluzakura group and cardiac arrest in the placebo group.
“(Fluzakura) treatment provided a significant and clinically meaningful benefit in overall survival compared to placebo in patients with refractory metastatic colorectal cancer,” the researchers wrote in the paper. lancet. “These data support the use of (Fluzakura) as a global treatment option for patients with refractory metastatic colorectal cancer.”
In the FRESCO trial, median overall survival for patients treated with Fluzacra was 9.3 months compared to 6.6 months for patients treated with placebo.
“Patients with metastatic disease are often frail and fatigued, both due to their condition and the treatments they have received. Oral chemotherapy provides a survival benefit despite treatment with previous therapies. “A non-invasive option is critically needed for the treatment of metastatic colorectal cancer,” said Dr. Kathy Eng of Vanderbilt University Medical Center in a news release. “Colorectal cancer is such a diverse disease that it is difficult to bring progress to patients whose cancer has spread. We look forward to bringing new solutions to the right patients.”
As Takeda explained in a news release, Fluzacra is a “selective oral inhibitor of VEGFR -1, -2, and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fluzakura has enhanced selectivity to limit off-target kinase activity, allowing flexibility for high drug exposure, sustained target inhibition, and potential use as part of combination therapy. Designed. Fluzakura has demonstrated a manageable safety profile and is being studied in combination with other anti-cancer therapies.”
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