Health
Endometrial cancer patients see new hope as FDA approves 'transforming' immunotherapy drug
The U.S. Food and Drug Administration (FDA) has approved a new drug for certain adult patients with endometrial cancer.
Jemperli (dostarlimab-gxly) — made by British pharmaceutical company GSK — is intended for people with primary advanced or recurrent forms of the cancer, according to the FDA’s Aug. 1 announcement.
It is an immunotherapy-based drug, which means it leverages the body’s immune system to attack cancer cells.
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In clinical trials, Jemperli showed an improved progression-free survival and overall survival for all patients, according to Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Florida.
“This class of drugs has been used in the second-line setting,” Slomovitz said — meaning they were only used if a first-line (primary) treatment was not effective or had intolerable side effects.
The FDA has approved a new drug for certain adult patients with endometrial cancer. (iStock)
“Moving them to first-line [status] here will yield better outcomes.”
This is the third FDA approval this year for immunotherapy in endometrial cancer, the doctor noted.
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“This is great news for our patients,” Slomovitz told Fox News Digital.
“Endometrial cancer has become the leading cause of death over all other gynecologic cancers, including ovarian cancer.”
Jemperli (dostarlimab-gxly) — made by British pharmaceutical company GSK — is intended for people who have primary advanced or recurrent forms of the cancer. (iStock)
Before the immunotherapy options became available, the only treatment for endometrial cancer was chemotherapy alone, Slomovitz said.
“These results are game-changing — it is unprecedented to have three approvals in such a short period of time.”
The most common side effects of all immunotherapy drugs are gastrointestinal, endocrine and dermatologic toxicities, the doctor noted.
“These results are game-changing — it is unprecedented to have three approvals in such a short period of time.”
“Patients should understand that adding immunotherapy to traditional chemotherapy has better results and the toxicity profile is manageable,” he added.
For doctors, Slomovitz emphasized the need to adjust quickly and make the newly approved drug a first-line treatment option for their patients.
GlaxoSmithKline (GSK) is the U.K.-based pharmaceutical company that makes Jemperli. (REUTERS/Dado Ruvic/Illustration/File Photo)
In June, the FDA approved Merck’s Keytruda (pembrolizumab) to be used in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial cancer.
“The Merck trial (pembrolizumab) showed a significant improvement in progression-free survival for all patients,” Slomovitz said.
In that same month, AstraZeneca’s Imfinzi (durvalumab) was approved for patients with advanced or recurrent disease who have a certain biomarker.
The AstraZeneca trial also showed improved progression-free survival for all patients.
All trials for the new cancer drugs were run through the GOG Foundation, which is the largest cooperative group for all gynecologic oncology research, Slomovitz noted.
“The addition of immunotherapy to chemotherapy provided improvement in survival outcomes without a negative impact on quality of life,” an oncologist said. (iStock)
In the trials, the use of immunotherapy drugs in combination with chemotherapy reduced the risk of disease progression by approximately 70% in patients whose tumors had certain biomarkers.
In other patients without that biomarker, there was still a “clinically and statistically significant improvement in time to progression, which is meaningful for our patients and has now led to FDA approvals in both biomarker settings,” Kathleen N. Moore, M.D., co-director of the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, told Fox News Digital.
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“These studies have transformed outcomes for patients with endometrial cancer and are poised to change the treatment landscape for the better into the future,” she added.
Shannon N. Westin, medical director of the Gynecologic Oncology Center at the University of Texas MD Anderson Cancer Center, said she is “thrilled” to have multiple new options for patients with advanced and recurrent endometrial cancer after years with no new therapies.
This is the third FDA approval this year for immunotherapy in endometrial cancer, the doctor noted. “This is great news for our patients,” an oncologist told Fox News Digital. (iStock)
“We no longer have to treat everyone in the same cookie-cutter fashion, and can instead employ precision medicine to improve survival for these survivors.”
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“The addition of immunotherapy to chemotherapy provided improvement in survival outcomes without a negative impact on quality of life,” she went on.
“This is the ideal scenario.”
Fox News Digital reached out to GSK for comment.
Over the two and a half years following the 2022 rollout of the 988 national suicide prevention hotline, the rate of suicides among young people in the United States dropped 11 percent below projections, decreasing most sharply in states with a higher volume of answered 988 calls, a new study has found.
The findings, published today as a research letter in JAMA, compared suicide deaths from July 2022 to December 2024 with sophisticated mathematical projections that were based on historical trends. This yielded good news, with 4,372 fewer suicides of adolescents and young adults, ages 15 to 34, than had been projected.
To ensure that the decline was related to the use of the hotline, researchers at Harvard Medical School teased out the trends in states with high and low usage of the hotline. The findings were striking: The 10 states with the largest increases in 988 calls experienced an 18.2 percent reduction in observed suicides compared with expected suicides; in the 10 states with the lowest uptake, the reduction was smaller, 10.6 percent.
The results suggest that the government’s investment in the 988 rollout has translated into “a measurable reduction of deaths,” said Dr. Vishal Patel, a resident physician at Brigham and Women’s Hospital and one of the authors of the study.
“What our study has added,” he said, “is evidence for the deeper benefit of the program, and that is, that at the population level, among young people at least, suicide mortality is lower than it would have been without the program.”
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He added, “The implication of that is that sustained funding for this program matters.”
The United States rolled out the three-digit hotline with bipartisan support in July 2022, replacing a 10-digit hotline number, and augmented it with a $1.5 billion investment in crisis center capacity. Since its inception, the service has fielded more than 25 million contacts, according to the Department of Health and Human Services. The agency has asked Congress for $534.6 million to fund the program for 2027.
Last summer, the Trump administration terminated one element of the hotline, the Press 3 option for L.G.B.T.Q.+ callers. The Substance Abuse and Mental Health Services Administration said that the Press 3 option was being discontinued because it had exhausted its funding from Congress and that the hotline would “focus on serving all help seekers.”
But advocacy groups and policymakers protested the decision, and in testimony before the Senate on Tuesday, the health secretary, Robert F. Kennedy Jr., said his agency was planning to restore the Press 3 option.
Dr. Patel said his group had become curious about measuring the program’s effectiveness after Press 3 was eliminated. While call volume and satisfaction surveys suggested that 988 was succeeding, he said, the harder question was, “Did the creation of this 988 program, the transition from the old hotline to this hotline, actually move the needle on suicide mortality?”
Experts said it was difficult to tease out the beneficial effect of 988 from other things that changed in 2022, the year that the new hotline was created. Around that time, suicide prevention programs were being introduced in schools, in faith communities and on social media, but more important, the pandemic was ending.
“We were finally out of this crazy time, and there was a sense of optimism and hope,” said Jonathan B. Singer, a professor of social work at Loyola University Chicago and a co-author of “Suicide in Schools.” He called the downward trend in youth suicides “encouraging, but it is tempered by the fact that we don’t have a good explanation as to why.”
The authors acknowledged that their findings could not account for the influence of social and economic changes, changes in mental health services or public awareness about services.
But they did make comparisons to exclude other possible explanations. The authors looked for similar effects among American adults over 65, who are less likely to use the hotline. In that group, there was a reduction in suicides that exceeded expectations, but it was smaller, at just 4.5 percent.
To ensure the decline in suicides did not reflect a general improvement in young-adult mortality, the researchers tracked cancer deaths, and found there was no change. They also looked at the rates of suicide among young people in England, where no change had been made to the national crisis line in that time period; they found no reduction in youth suicides there.
Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, said she was persuaded that the hotline had contributed to the improvement in suicide rates, in part because it did not appear among English youths or in older Americans.
“To me, that really helps hone in that this might really be the differentiator,” she said. “We are seeing potentially a pretty significant decline in suicides among young people. For public policy, this is strong evidence to double down on that we are doing.”
Emily Hilliard, a senior press secretary at the Department of Health and Human Services, said H.H.S. and SAMHSA are “committed to ensuring that all Americans have access” the 988 line, which she said “clearly provides lifesaving support, helping millions of people every year.”
If you are having thoughts of suicide, call or text 988 to reach the 988 Suicide and Crisis Lifeline or go to SpeakingOfSuicide.com/resources for a list of additional resources.
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A highly contagious digestive virus is surging across the U.S., experts warn.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain.
The virus primarily affects infants and young children, but there have also been outbreaks in elderly populations, such as nursing homes.
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Data from the Centers for Disease Control and Prevention shows that in the week ending April 4, out of 2,329 rotavirus tests, 7.3% were positive for the infection. Last year’s highest infection rate was 6.77% as of the week ending April 19.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain. (iStock)
“We’re seeing a lot of rotavirus in the wastewater right now,” Dr. Marc Siegel, Fox News senior medical analyst, confirmed to Fox News Digital. “Testing for rotavirus is way down, but the percentage of positive tests is up.”
While the virus typically peaks in the spring, it is not currently slowing down, he noted.
Why cases may be rising
Patricia Pinto-Garcia, M.D., a medical editor at GoodRx who is based in California, said there are several possible reasons for the rotavirus spike.
“Vaccine rates are down overall among young children, as they decreased during COVID,” she told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.”
The rotavirus vaccine series must be completed by the time a child is 8 months old, she noted.
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As a result of the declining vaccinations, herd immunity isn’t protecting vulnerable children, according to Pinto-Garcia. “Children who haven’t finished the vaccine series yet, are too young to get vaccinated, or can’t get the vaccine due to medical illness are more likely to get exposed to the illness because other children aren’t vaccinated,” she said.
Siegel noted that before the vaccine became available, rotavirus resulted in 55,000 to 70,000 in the U.S. per year.
“Vaccine rates are down overall among young children, as they decreased during COVID,” a doctor told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.” (iStock)
“I am concerned that the vaccination rate has been declining over the past seven years and is continuing to decline in the current climate of vaccine skepticism,” he said.
Surveillance methods are also much better than they used to be, Pinto-Garcia noted, which means public health experts are able to pick up and track cases better than ever before.
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“But we see that rotavirus-related healthcare visits are also up, so improved detection is not the only reason we are seeing this spike,” she said.
The COVID pandemic also disrupted the pattern of infections, according to Pinto-Garcia, so it’s “tricky” to compare the current levels against older cycles.
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor,” she added.
Transmission and risk
Dr. Zachary Hoy, a pediatric infectious disease specialist at Pediatrix Medical Group based in Nashville, Tennessee, often sees young patients with rotavirus.
“Rotavirus is spread via the fecal-oral route, meaning that a person comes into contact with virus droplets from contact with other children or adults, or from contact with objects such as toys that have been contaminated with the virus from someone who is sick,” he told Fox News Digital. “This can lead to outbreaks, especially at schools where many young children share the same toys.”
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor.”
Rotavirus is associated with many dehydration cases in the hospital due to the degree of diarrhea, according to Hoy.
In some severe cases, the virus can lead to seizures due to electrolyte imbalances from dehydration and loss of electrolytes in the stool.
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“Younger children do not have the reserves that older children and adults have, so they can become more dehydrated quicker and develop more severe electrolyte imbalances, leading to more severe infections,” Hoy said.
“Patients with problems with their immune systems or on medications that can decrease their immune systems can have more severe and prolonged infections, too.”
Treatment and care
Because rotavirus is a viral infection, antibiotics are not effective against it. There is no specific antiviral treatment for the condition, with doctors typically recommending supportive care.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” Hoy told Fox News Digital. “Sometimes it can take up to two to three days of IV fluids to help get patients rehydrated.”
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Blood draws are often necessary to evaluate patients’ electrolyte levels, such as sodium, potassium, calcium and magnesium, according to the doctor.
“If these electrolyte levels are significantly low, sometimes patients need special IV solutions or individual electrolyte medications,” he added.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” a doctor told Fox News Digital. (iStock)
Dr. Daniel Park, medical director of the Pediatric Emergency Department at UNC Health in Chapel Hill, North Carolina, noted that most children recover with supportive care, but parents should seek medical attention if a child shows signs of dehydration. Those include decreased urination, lethargy or inability to keep fluids down.
“While rare, rotavirus can be life-threatening in vulnerable populations, especially very young infants or children with underlying medical conditions,” Park told Fox News Digital.
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Prevention strategies
Given the lack of antiviral medications for rotavirus, doctors emphasize the importance of prevention, primarily the vaccine.
There are two rotavirus vaccines – Rotateq (a three-dose series) and Rotarix (a two-dose series). They are given starting at age 2 months as oral drops, not injections, according to Hoy.
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“It’s important to get the rotavirus vaccines on schedule, because these younger infants are at greatest risk if they get rotavirus,” he advised.
Other recommended prevention methods include handwashing with soap and water.
Every day we’re faced with a zillion small choices: Go to sleep early, or watch one more episode of that Netflix drama. Call an old friend to catch up, or cruise social media. Of course, no single action will guarantee a long, healthy life or doom you to an early grave. But those little daily decisions do add up, and over the long term they can make a difference when it comes to both your longevity and your health span, the amount of life spent in relatively good health.
Scroll through this theoretical “day in the life” and select the option that best fits your typical day. Not every situation will apply perfectly, but think about which choice you’d be most likely to make. This isn’t a formal scientific assessment. The goal here isn’t to assign you a “good” or “bad” score, but to help you understand the central factors that shape the way we age and how long we live.
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