Metastatic colorectal cancer patients could find hope in new FDA-approved treatment

This month brought some hopeful news for people who are battling metastatic colorectal cancer.

The U.S. Food and Drug Administration (FDA) on Nov. 8 approved a new oral medicine called Fruzaqla (fruquintinib) for the treatment of patients with previously treated metastatic colorectal cancer. 

Up until now, patients with this condition have had limited treatment options — including surgery, chemotherapy, radiation and immunotherapy.

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Fruzaqla is the first chemotherapy-free treatment option to be approved for metastatic colorectal cancer in more than a decade, according to a press release from the drug’s manufacturer, Takeda. 

“We are very encouraged by the FDA’s decision, given the pressing need for new treatments for individuals with metastatic colorectal cancer who have had limited options and continue to face poor outcomes,” Teresa Bitetti, president of the Global Oncology Business Unit at Takeda in Cambridge, Massachusetts, wrote in a statement to Fox News Digital.

Fruzaqla is the first chemotherapy-free therapy to get approved for metastatic colorectal cancer treatment in more than a decade, according to a press release from the drug’s manufacturer, Takeda.  (iStock)

“We see this as a positive step forward for patients and their providers as they evaluate options at this stage in their battle with colorectal cancer.” 

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The FDA’s approval comes after two large Phase 3 trials that were published in The Lancet and in the Journal of the American Medical Association.

Participants took 5 mg of the medication orally once per day for the first 21 days of each 28-day cycle “until disease progression or unacceptable toxicity,” the FDA stated in a release on its website.

Some 106,970 new cases of colon cancer and 46,050 new cases of rectal cancer are expected in the U.S. in 2023, says the American Cancer Society (ACS). (iStock)

In both trials, the drug extended overall survival and showed “consistent benefit” among 734 patients.

In one of the trials, called FRESCO, the median overall survival was 9.3 months on Fruzaqla compared to 6.6 months among the placebo group.

In the other trial, FRESCO-2, the median overall survival on the drug was 7.4 months compared to 4.8 months.

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“Patients with metastatic disease are often fragile and fatigued, due to both their condition as well as the therapies they have been exposed to,” said Cathy Eng, M.D., at Vanderbilt University Medical Center in Nashville, Tennessee, in the press release.

“An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer.”

Participants took 5 mg of the medication orally once per day for the first 21 days of each 28-day cycle “until disease progression or unacceptable toxicity,” the FDA stated in a release on its website. (iStock)

Maged Khalil, M.D., a hematologist and medical oncologist at Lehigh Valley Topper Cancer Institute of Leigh Valley Health Network in Pennsylvania, was not involved in the making or testing of the new medication but commented on its potential.

“The FDA approval of fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy has the potential to benefit overall patient survival in refractory metastatic colorectal cancer, notably including a 34% reduction in the risk of death,” he told Fox News Digital. 

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“This is a monumental and significant evolution in our ability to treat patients with metastatic colorectal cancers,” Khalil went on. 

“Studies to combine Fruquintinib with checkpoint inhibitors are in progress, and it would be interesting to see these results, all to the benefit of patients.”

The Food and Drug Administration (FDA) approved Fruzaqla on Nov. 8 for the treatment of patients with previously treated metastatic colorectal cancer.  (iStock)

The most common adverse reactions, reported by roughly 20% of patients, included hypertension, protein in urine, voice disorders, abdominal pain, diarrhea, muscle weakness, and swelling and blistering on the palms of the hands and soles of the feet, according to the FDA.

Approximately 106,970 new cases of colon cancer and 46,050 new cases of rectal cancer are expected in the U.S. in 2023, according to the American Cancer Society (ACS).

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About 52,550 people are expected to die of the disease this year.

Approximately 70% of people with colorectal cancers will experience metastatic disease, which is the leading cause of mortality among patients. 

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