This month brought some hopeful news to those battling metastatic colorectal cancer.
The U.S. Food and Drug Administration (FDA) on November 8 approved a new oral drug called Fluzacra (fruquintinib) for the treatment of previously treated patients. metastatic colorectal cancer.
Until now, patients with this disease have had limited treatment options, including surgery, chemotherapy, radiation therapy, and immunotherapy.
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Fluzakura is the first non-chemotherapy treatment option approved for metastatic colorectal cancer in more than a decade, according to a press release from drug manufacturer Takeda Pharmaceuticals.
“Given the urgent need for new treatments for patients with metastatic colorectal cancer, who continue to face limited options and poor prognosis,” said Teresa Vitetti, President of Takeda’s Global Oncology Business Unit. “We are very encouraged by the FDA’s decision.” cambridge, massachusettssaid in a statement to Fox News Digital.
Fluzakura is the first chemotherapy-free treatment approved for metastatic colorectal cancer in more than a decade, according to a press release from drug manufacturer Takeda Pharmaceuticals. (St. Petersburg)
“We believe this is a positive step forward for patients and their healthcare providers as they evaluate their options at this stage in the fight against colorectal cancer.”
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FDA approval came after two large phase 3 trials published in The Lancet and Journal of the American Medical Association.
Participants took 5 mg of the drug orally once daily for the first 21 days of each 28-day cycle “until disease progression or unacceptable toxicity,” the FDA said in a release on its website. Ta.
According to the American Cancer Society (ACS), there will be approximately 106,970 new cases of colon cancer and 46,050 new cases of rectal cancer in the United States in 2023. (St. Petersburg)
In both trials, the drug increased overall survival and showed “consistent benefit” in 734 patients.
In one trial, called FRESCO, median overall survival was 9.3 months in the Fluzakura group compared to 6.6 months in the placebo group.
In another trial, FRESCO-2, median overall survival with the drug was 7.4 months versus 4.8 months.
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“Patients with metastatic disease are often frail and fatigued, both because of their condition and the treatment they have received,” said Kathy Eng, MD, of Vanderbilt University Medical Center. Nashville, Tennesseestated in the press release.
“A non-oral chemotherapy option that provides survival benefits despite treatment with previous therapies is critical for the treatment of metastatic colorectal cancer.”
Participants took 5 mg of the drug orally once daily for the first 21 days of each 28-day cycle “until disease progression or unacceptable toxicity,” the FDA said in a release on its website. Ta. (St. Petersburg)
Majid Khalil, M.D., hematologist and medical oncologist at Lehigh Valley Topper Cancer Institute, Lee Valley Health Network; in Pennsylvaniawas not involved in manufacturing or testing the new drug, but commented on its potential.
“FDA approval of fruquintinib (Fluzakura, Takeda Pharmaceutical Company) for adult patients with metastatic colorectal cancer who have received fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy is particularly important for patients with refractory metastatic colorectal cancer. , including a 34% reduction in the risk of death,” he told FOX News Digital.
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“This is a monumental and important evolution in our ability to treat patients with metastatic colorectal cancer,” continued Dr. Khalil.
“Studies combining fruquintinib with checkpoint inhibitors are underway and it will be interesting to see these results, all of which will be of benefit to patients.”
On November 8, the Food and Drug Administration (FDA) approved Fluzakura for the treatment of patients with previously treated metastatic colorectal cancer. (St. Petersburg)
The most common side effects are reported by approximately 20% of patients. including high blood pressureThe FDA says it can cause protein in the urine, impaired speech, abdominal pain, diarrhea, muscle weakness, and swelling or blisters on the palms and soles of the feet.
According to the American Cancer Society (ACS), there will be approximately 106,970 new cases of colon cancer and 46,050 new cases of rectal cancer in the United States in 2023.
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About 52,550 people are expected to die from the disease this year.
Approximately 70% of colorectal cancer patients experience metastatic disease, which is the leading cause of patient death.
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