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Patients with metastatic colorectal cancer could find hope in new FDA-approved treatment

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Patients with metastatic colorectal cancer 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. 

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“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.

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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.

Colon cancer

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.”

Woman taking pill

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.”

FDA Headquarters

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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Lose Up to 13 Pounds Per Week by Adding This Powder Supplement to Your Coffee

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‘Smart mask’ could detect asthma, COPD and other medical conditions, researchers say

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‘Smart mask’ could detect asthma, COPD and other medical conditions, researchers say

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Your breath could hold clues to your health, researchers say — and they have developed a “smart mask” to tap into them.

Wei Gao, professor of medical engineering at the California Institute of Technology (Caltech) in Pasadena, led the team that created the EBCare, a mask that analyzes the chemicals in someone’s breath to detect any existing health issues.

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The mask is designed to screen for medical conditions like respiratory infections, COPD (chronic obstructive pulmonary disease), asthma and post-COVID infections, according to a press release from Caltech.

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EBCare works by cooling the breath to convert it into a liquid, then transports it to sensors to be analyzed for specific biomarkers.

Researchers have developed a “smart mask” (pictured at left) to detect signs of medical conditions. (Caltech/Wei Gao and Wenzheng Heng; iStock)

In an email to Fox News Digital, lead researcher Gao noted the mask’s ability to enable “continuous, real-time monitoring of exhaled breath condensate (EBC) in a non-invasive and wearable format.”

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“This technology has the potential to revolutionize the way we monitor respiratory health by providing valuable insights into conditions like asthma, COPD and other metabolic disorders,” Gao said, noting that it could be a path to more personalized health care.

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“It can also be applied to pandemic management by monitoring respiratory infections on a wide scale,” he added.

The ultimate goal is for the EBCare technology to go beyond respiratory diseases, Gao noted. 

“As research progresses, we envision that the smart mask can be adapted to detect a wider range of biomarkers, including those related to metabolic, cardiovascular and infectious diseases,” he said.

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Smart mask technology

This schematic shows the process by which the smart mask can detect chemicals in the breath, such as nitrite, which is an indicator of airway inflammation. (Caltech/Wei Gao and Wenzheng Heng)

A study of the mask’s capabilities included 31 healthy adults who wore the EBCare in real-life settings over a 14-hour span, according to Caltech. They only removed the mask for three-minute intervals to eat.

Ten of the participants were smokers, 10 had asthma, nine had COPD and 12 had recently recovered from COVID-19.

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The masks accurately detected the biomarker for asthma and COPD in participating patients. They also successfully detected signs of kidney disease.

EBCare also produced accurate readings of blood alcohol levels.

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“Monitoring alcohol levels in real time offers a non-invasive and continuous alternative to breathalyzers or blood tests,” Gao said.

“We would need to see at least a few clinical studies demonstrating that the masks can diagnose better — or more rapidly or with more sensitivity — than the standard of care.”

The research — which was funded by the National Institutes of Health, the National Science Foundation, the Tobacco Related Disease Research Program, and the U.S. Army Medical Research Acquisition Activity — was published in the journal Science on Aug. 29.

The idea is not for the smart mask to replace traditional medical diagnosis, but to provide “early warning” through continuous health monitoring during daily activities and to “bridge the gap” between doctor’s visits, Gao said.

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“The goal is to identify subtle physiological changes before they develop into more severe conditions, giving individuals the opportunity to take proactive steps in managing their health,” he said.

This is especially important for those who need regular monitoring, such as patients with chronic conditions or those recovering from respiratory infections like COVID-19, according to Gao.

Man with asthma

The mask (not pictured) is designed to screen for medical conditions like respiratory infections, COPD (chronic obstructive pulmonary disease), asthma and post-COVID infections. (iStock)

“I recommend that health care providers consider integrating real-time EBC analysis technology into their diagnostic and monitoring practices, especially for chronic conditions like asthma and COPD,” he said. 

“For individuals, the ability to monitor one’s health non-invasively through a wearable device offers the opportunity to be more proactive in managing personal health, which can lead to early intervention and better health outcomes.”

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MarkAlain Déry, DO, MPH, infectious disease doctor and chief innovation officer at Access Health Louisiana, who was not involved with the development of the smart mask, agreed that it is an “exciting concept.”

“Could it work? Sure,” he told Fox News Digital. 

Wei Gao

Wei Gao, professor of medical engineering at the California Institute of Technology in Pasadena, led the team that created the EBCare mask. (Caltech)

“However, we would need to see at least a few clinical studies demonstrating that the masks can diagnose better — or more rapidly or with more sensitivity — than the standard of care,” he went on. 

“Then, we would need studies that demonstrate clinical improvement.”

Potential limitations

Some external doctors not involved in the mask’s development questioned whether this mode of data collection is beneficial.

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“While the mask introduces an innovative method to monitor exhaled breath condensate (EBC), we need to ask an important question: Do these continuous, real-time measurements genuinely make a difference in everyday life?” said Dr. Brett Osborn, a Florida neurosurgeon, in a conversation with Fox News Digital. 

“For the average person, the biomarkers it detects — ammonium, pH, nitrite and alcohol — do not need constant monitoring, especially when routine blood tests can provide this information more accurately and with greater relevance.”

Woman donating blood

“For the average person, the biomarkers it detects … do not need constant monitoring, especially when routine blood tests can provide this information more accurately and with greater relevance,” a doctor said. (iStock)

Osborn believes that the concept of the EBCare mask is better suited for “specific, high-stakes environments,” such as real-time monitoring of toxic gases in military or industrial settings. 

“However, for the average person, especially in a post-pandemic world, the idea of wearing a mask like this is counterproductive,” he said. 

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Dr. John W. Ayers, PhD, vice chief of innovation in the Division of Infectious Diseases and Global Public Health at the University of California San Diego, also questioned the idea of having patients with asthma or COPD — who already experience breathing difficulties — wear the masks.

“For the average person, especially in a post-pandemic world, the idea of wearing a mask like this is counterproductive.”

The lead researcher, Gao, responded to some of these comments.

“While routine blood tests are indeed reliable, they are typically periodic and require a clinical setting, which limits their ability to capture dynamic, day-to-day physiological changes,” he told Fox News Digital. 

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“The real innovation of the EBCare mask lies in its ability to continuously monitor health in real time, offering insights that might not be detectable with intermittent tests.”

Lung diagram

For individuals managing chronic conditions like asthma, COPD or metabolic disorders, fluctuations in certain biomarkers can provide early warning signs, according to the researchers. (iStock)

For individuals managing chronic conditions like asthma, COPD or metabolic disorders, fluctuations in certain biomarkers can provide early warning signs before symptoms worsen, allowing for timely intervention, according to the researcher. 

Gao, however, did acknowledge some limitations with the EBCare device.

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“One limitation was the relatively small sample size in some of the clinical trials, particularly for conditions like COPD and asthma,” he told Fox News Digital. 

“Future studies with larger and more diverse populations will help to further validate the device’s performance across a broader range of conditions and environments.”

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Dr. Will Cole’s Gentler Twist on Intermittent Fasting for Weight Loss Helps Burn Fat at Double Speed

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Dr. Will Cole’s Gentler Twist on Intermittent Fasting for Weight Loss Helps Burn Fat at Double Speed


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