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‘Major step forward’ for adult patients as new blood cancer drug receives FDA approval

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‘Major step forward’ for adult patients as new blood cancer drug receives FDA approval

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Talvey, a new antibody-based therapy for adult patients with tough-to-treat blood cancers such as multiple myeloma. The drug is made by Johnson & Johnson. 

This is a “major step forward” for the myeloma field, according to Dr. Ola Landgren, M.D., PhD, chief of the Myeloma Program at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

“This is the first myeloma drug designed to target the protein called GPRC5D, which is expressed on the surface of myeloma cells,” Landgren told Fox News Digital. 

“It is a new mechanism of action.”

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The FDA grants “accelerated approval” to enable earlier availability of medications that treat serious conditions, according to its website.

Given the “huge unmet clinical need,” Landgren said there is an ongoing need to continue developing safe, effective drugs to target the disease. 

For patients just starting on the new drug, Talvey, the first few doses are given in the hospital because there is an early risk of low-grade fever and immunological reactions. The drug has been approved as a weekly or biweekly injection administered by physicians. (iStock)

“This drug is an example of that important momentum,” he said.

Talvey (talquetamab) is intended for multiple myeloma patients who have received at least four prior types of treatment and have a “poor prognosis,” per a press release from Johnson & Johnson.

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The drug has been approved as a weekly or biweekly injection administered by physicians.

In clinical studies, Talvey showed “impressive response rates” in myeloma patients who had received prior treatments, said Landgren, who is a renowned hematologist/oncologist specializing in multiple myeloma, smoldering myeloma and related plasma cell disorders.

“If everything is done correctly, these drugs are overall very safe and effective.”

“The overall response rate is 70% in patients who failed four prior lines of myeloma therapy,” he said.

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“A major clinical issue is that the myeloma tumor cells eventually develop resistance to our therapies,” he went on. “For patients who fail several lines of therapy, eventually, there may not be many treatment options left.”

Risks and limitations

Because it is an immunotherapy drug, Talvey has the potential to cause immunosuppression, which may lead to an increased risk of infections, Landgren warned.

The most common adverse effects included an altered or impaired sense of taste, dry mouth and difficulty swallowing. 

Some patients also experienced weight loss, skin reactions, serious infections, low white blood cell count and low blood platelets, per the press release.

Johnson & Johnson

The FDA has granted accelerated approval for Johnson & Johnson’s new drug, Talvey, an antibody-based therapy for adult patients with tough-to-treat blood cancers like multiple myeloma. (iStock)

“Trained health care providers know what to look for clinically and how to do lab work to monitor the individual patient’s immune status,” Landgren told Fox News Digital. “If everything is done correctly, these drugs are overall very safe and effective.”

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For patients just starting on the drug, the first few doses are given in the hospital because there is an early risk of low-grade fever and immunological reactions, although Landgren said these symptoms are manageable and usually resolve quickly. 

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“Ongoing studies are seeking to define optimal ways to pre-medicate patients for the first few doses to limit side effects such as fever and immunological reactions, so these drugs can be given outpatient from day one,” he said. 

“We are not yet there, but I think we are moving in this direction.”

‘The future is bright’

With the large number of new, effective and safe drugs, Landgren said “the future is bright” for patients with multiple myeloma. 

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“We are moving from chemotherapy to immunotherapies,” he said. “We are able to achieve high rates of no detectable disease (called minimal residual disease-MRD-negativity) in myeloma patients.”

Doctor with patient

Overall survival for patients with myeloma is improving every year, a doctor told Fox News Digital. (iStock)

In another mark of progress, overall survival for patients with myeloma is improving every year, the doctor noted. 

“When I was in fellowship, overall survival for myeloma was one to two years — these days, we are talking 10 to 20 years or longer,” Landgren said. 

“We still need to develop curative therapies,” he said. “We (at Sylvester) and other groups are working on that.”

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Given that myeloma is considered a rare cancer — affecting 35,000 patients every year in the U.S. — the doctor noted that a key aspect is for patients to have access to specialized care.

A myeloma specialist can review the patient’s individual case, develop an optimal treatment plan and optimize the person’s prognosis and quality of life, he said.

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Your July 2024 Horoscope: Zodiac Sign Monthly Forecast | Woman's World

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Childhood medical myths debunked as experts weigh in on 5 common warnings

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Childhood medical myths debunked as experts weigh in on 5 common warnings

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Mothers might know best, but it’s not always easy to separate fact from fiction when it comes to health advice.

A new report from University of California San Francisco (UCSF) Health has broken down several common wellness myths that children often hear while growing up.

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Fox News Digital spoke with experts who revealed the truth behind common medical misconceptions.

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Here are five.

Myth 1. Ginger ale relieves stomach aches

While actual ginger can help ease a stomach ache, most commercial ginger ales don’t actually contain the real thing, Michelle Jaelin, a registered dietitian practicing in Ontario, Canada, told Fox News Digital.

A new report from University of California San Francisco (UCSF) Health reveals the truth about several common wellness myths that children often hear while growing up. (iStock)

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This childhood myth persists as parents give ginger ale to children because it’s sweet and bubbly, she said.

“It makes parents feel better that they are doing something for their child when they aren’t feeling well, and the myth persisted as a drink that helps a stomach ache,” Jaelin said.

The carbonated beverages could actually make the stomach pain even worse by increasing gas in the digestive tract, according to Healthline’s website.

Kid eating chicken soup

Chicken soup has been viewed as a popular cold remedy since at least the 12th century, according to the National Institutes of Health (NIH). (iStock)

Drinks with real ginger also tend to contain excess added sugar, experts said – essentially the equivalent of soda that may worsen stomach pain. 

Myth 2. Gum stays in your stomach for seven years

“Swallowed gum does not stay in your stomach for [seven] years, as the myths suggest,” Su-Nui Escobar, a registered dietitian based in Miami, Florida, told Fox News Digital.

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“While swallowing gum is not recommended, if you do so accidentally, you will likely pass it like any other indigestible food.”

ASK A DOCTOR: ‘IS IT DANGEROUS TO SWALLOW GUM?’

The gum will pass through the stomach within two hours and be excreted in the stool after approximately two to five days, just like other foods, according to the recent UCSF report.

Although chewing gum can stick to many surfaces — including walls or desks — it travels mostly intact through the gastrointestinal tract without sticking to the intestinal walls, the report notes.

Kid chewing gum

“Swallowed gum does not stay in your stomach for [seven] years, as the myths suggest,” an expert told Fox News Digital. (iStock)

But experts still caution against children swallowing gum, because substantial amounts might cause an intestinal blockage, Escobar warned.

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This is a particular concern among children who have underlying constipation, according to Mayo Clinic’s website.

“If you suspect a blockage, seek immediate medical attention,” Escobar advised.

Myth 3. You shouldn’t swim for 30 minutes after eating

As summer kicks into high gear, there is good news for any swimmer itching to get in the water after lunch. Yes, it is usually OK to swim right after you eat.

The myth that you shouldn’t swim immediately after eating stems from a theoretical concern that blood flow will be diverted away from the arms and legs to help digest food, potentially leading to an increased risk of drowning.

“Based on current research, eating before swimming is not affiliated with a risk of drowning, and can be dismissed as a myth.”

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But a comprehensive American Red Cross scientific review on the effects of eating before swimming showed no effect on performance in the water after a meal.

“A recent literature review did not provide any information related to an increased risk of drowning due to consuming food before swimming,” Jodi Jensen, PhD, member of the American Red Cross Scientific Advisory Council in Virginia, told Fox News Digital.

AS DROWNING DEATHS INCREASE, EXPERTS OFFER WATER SAFETY TIPS

“There is no supporting evidence from a major medical or safety organization that recommends refraining from eating before engaging in aquatic activities such as swimming,” added Jensen, who is also an assistant professor and aquatics director at Hampton University in Hampton, Virginia.

little-girl-eating-ice-pop-by-pool

“There is no supporting evidence from a major medical or safety organization that recommends refraining from eating before engaging in aquatic activities such as swimming,” an expert told Fox News Digital. (iStock)

“Based on current research, eating before swimming is not affiliated with a risk of drowning, and can be dismissed as a myth.”

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Although study participants experienced “minimal” side effects at different time intervals after eating, some outside experts do recommend waiting a bit after a meal if you plan to swim laps or compete to avoid any stomach cramping or digestive issues.

Myth 4. Chicken soup cures a cold

Chicken soup has been viewed as a popular cold remedy since at least the 12th century, according to the National Institutes of Health (NIH).

ASK A DOCTOR: ‘DOES CHICKEN SOUP REALLY HELP CURE A COLD?’

“Chicken soup is warm and comforting when you’re sick, but it’s not a cure,” Jaelin told Fox News Digital.

“Chicken soup is warm and comforting when you’re sick, but it’s not a cure.”

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“Drinking any hot broth when your sinuses are stuffed can help to clear them out.”

The steam from the chicken broth may relieve a sore throat and congested sinuses, the NIH noted.

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When battling a cold, get plenty of clear fluids to help regulate body temperature and promote improved immune system function, said Jaelin.

“Chicken soup counts toward overall fluid intake,” she added.

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It also helps prevent dehydration and clear out mucus, the NIH noted.

Myth 5. You will ruin your eyes if you sit too close to the TV

Sitting too close to the TV will not damage your eyes, though it may cause eye strain, according to the American Academy of Ophthalmology.

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To prevent eye strain while watching television, experts recommend keeping the room well-lit and taking occasional breaks from the screen.

little-kid-watching-TV

Sitting too close to the television will not damage your eyes, but may cause eye strain, according to the American Academy of Ophthalmology. (iStock)

“Children can focus at very close distances better than adults, and may not develop the same eye strain symptoms,” Nishika Reddy, M.D., assistant professor of ophthalmology at Moran Eye Center’s Midvalley Health Center at University of Utah in Murray, Utah, told Fox News Digital. 

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It may be a red flag, though, if children are watching television too closely, experts warned.

The behavior may indicate an underlying vision issue that should be addressed, the UCSF report noted.

kids-closely-watching-TV

The American Academy of Pediatrics says high-quality digital media can be introduced to children between 18 and 24 months of age (only when supervised by parents or caregivers). The academy also recommends limiting screen time to one hour a day for children ages 2 to 5. (iStock)

“See an eye care provider to perform an eye exam for your child,” Reddy recommended.

A more concerning issue is the indirect effect of too much screen time, according to the report.

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Although experts say there is no one-size-fits-all guideline when it comes to children and screen time, the American Academy of Pediatrics says high-quality digital media can be introduced to children between 18 and 24 months of age (only when supervised by parents or caregivers). 

The academy also recommends limiting screen time to one hour a day for children ages 2 to 5.

Fox News Digital reached out to UCSF for additional comment about its new study.

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The Anti-Inflammatory and Mediterranean Diets: Two Immune System-Boosting Diets That Don't Skimp on Flavor | Woman's World

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