{"id":104474,"date":"2025-09-22T18:46:29","date_gmt":"2025-09-22T22:46:29","guid":{"rendered":"https:\/\/cablemanpro.com\/wallstreetpr\/cancer-drug-could-double-as-autism-therapy-and-is-poised-for-fda-approval-104474"},"modified":"2025-09-22T18:46:29","modified_gmt":"2025-09-22T22:46:29","slug":"cancer-drug-could-double-as-autism-therapy-and-is-poised-for-fda-approval","status":"publish","type":"post","link":"https:\/\/cablemanpro.com\/wallstreetpr\/cancer-drug-could-double-as-autism-therapy-and-is-poised-for-fda-approval-104474","title":{"rendered":"Cancer drug could double as autism therapy, and is poised for FDA approval"},"content":{"rendered":"
\n

During a Monday press conference about various autism topics<\/a>, federal health officials noted the potential for an existing cancer drug to double as therapy for the neurodevelopmental condition.<\/p>\n

FDA Commissioner Marty Makary, National Institutes of Health (NIH) Director Jay Bhattacharya, and Centers for Medicare and Medicaid Services Administrator Mehmet Oz discussed research suggesting that leucovorin, a prescription vitamin<\/a> used to treat cancer and anemia, is effective in off-label use for children with autism.<\/p>\n

The FDA plans to approve prescription leucovorin as a “potential treatment for speech-related deficits associated with ASD,” according to a press release from HHS. The agency will update the label for leucovorin to indicate treatment for cerebral folate deficiency, which has been associated with autism.<\/p>\n

PRESIDENT TRUMP TIES AUTISM TO WIDELY USED OVER-THE-COUNTER DRUG<\/strong><\/a><\/p>\n

After the label update, state Medicaid programs will be able to cover the drug for autism treatment, the release stated.\u00a0<\/p>\n

The NIH will also launch new research initiatives into leucovorin’s safety and effectiveness.<\/p>\n

Studies have shown that leucovorin could help some non-verbal children<\/a> gain the ability to speak.<\/p>\n

Leucovorin functions similarly to folic acid, helping to restore folate levels<\/a> in patients who may have difficulty absorbing or using it, according to Katy Dubinsky, a New York pharmacist and the CEO and co-founder of Vitalize, a private supplement company.<\/p>\n

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“Leucovorin is FDA-approved to reduce the toxic effects of high-dose methotrexate in cancer treatment and to prevent or treat certain types of anemia caused by folate deficiency,” Dubinsky previously told Fox News Digital.<\/p>\n

While leucovorin isn\u2019t yet prescribed<\/a> for the treatment of autism, some families have found that its off-label use has led to significant improvements in autistic children\u2019s communication skills, experts say.<\/p>\n

Richard E. Frye, M.D., Ph.D., a behavioral child neurologist in Arizona, has studied the drug in his research of experimental treatments for children with autism spectrum disorder.<\/p>\n

“Leucovorin is a special form of vitamin B9 that is water-soluble and does not build up in your body,” he previously told Fox News Digital.\u00a0<\/p>\n

RISING AUTISM RATES NOW AFFECT 3% OF CHILDREN, SAYS CDC REPORT<\/u><\/strong><\/a><\/p>\n

“Folates have been found to be safe long-term for many years and that is why we supplement our food with folate.”<\/p>\n

Leucovorin’s main benefit for children with autism is improvement in language, Frye said, but other advantages may include enhanced social function, reduced repetitive behaviors and stronger attention skills<\/a>.<\/p>\n

“We do find that leucovorin helps a substantial number of children with autism,” he said. “Language is one of the most obvious things, so that is what we measured in our clinical trial.”<\/p>\n

Dr. Marc Siegel,<\/u><\/a> clinical professor of medicine at NYU Langone Health and Fox News’ senior medical analyst, also spoke to Fox News Digital about why the drug may have this positive impact.<\/p>\n

“Central folate deficiency is a lack of folate in the brain, which can interfere with neurological function<\/a>,” he said earlier this year. “A high percentage of children with autism spectrum disorder have been found to have antibodies against folic receptor alpha in the brain.”<\/p>\n

Leucovorin is converted to folate in the brain by a different pathway, Siegel said.<\/p>\n

“Small studies are showing that it improves neurological function<\/a> and communication skills in kids with ASD, but larger studies need to be done.”<\/p>\n

The fact that leucovorin has already been used long-term helps to reduce the associated risk, doctors say.<\/p>\n

“One of the advantages of using leucovorin is that it’s been used for decades to protect the body from the effects of chemotherapy<\/a>, so we know what dose to use and any side effects it may produce,” Frye told Fox News Digital.<\/p>\n

However, some children do become “extremely hyperactive,” do not respond to leucovorin and need alternative treatments, the doctor noted.<\/p>\n

It\u2019s important for families to work with a medical professional<\/a> when exploring the use of leucovorin for autism, he advised.<\/p>\n

“Leucovorin is given at much higher doses than regular vitamins, so it\u2019s very important to work with a doctor knowledgeable in how to prescribe it,” Frye said.\u00a0<\/p>\n

While leucovorin is available at pharmacies, Frye said some children need a compounded form because they are sensitive to some of the additives in commercial products.<\/p>\n

“Our goal is to get leucovorin approved by the FDA for autism so it can be widely prescribed to children<\/a> as one of the first treatments once they are diagnosed,” he previously said.<\/p>\n

Dubinsky agreed physicians may prescribe the “widely used and well-tolerated drug” for autism treatment based on their “clinical judgment and emerging evidence” \u2014 but also stressed the importance of clinical trials.<\/p>\n

“FDA approval would provide stronger medical backing, making it a recognized treatment rather than just an off-label option,” she told Fox News Digital.\u00a0<\/p>\n

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER<\/u><\/strong><\/a><\/p>\n

“This could lead to insurance coverage, standardized dosing guidelines and broader acceptance in the medical community<\/a>.”<\/p>\n

Siegel added that leucovorin is a “safe drug” and should be considered for large-scale use based on the findings of recent research.<\/p>\n

Frye said there is “no magic bullet” for autism, with many children benefiting from a combination of multiple treatments.\u00a0<\/p>\n

“It is unlikely that leucovorin will be used alone \u2014 it must be used with behavioral and speech therapy,” he said. “We believe that leucovorin can improve outcomes<\/a> for these therapies.”<\/p>\n

Andy Shih, Ph.D., chief science officer of Autism Speaks in New York, noted that every child\u2019s experience with autism is unique.<\/p>\n

“There is little evidence to suggest that the benefits observed [in individual cases] can be generalized to the broader autistic community,” he previously told Fox News Digital.\u00a0<\/p>\n

For more Health articles, visit\u00a0<\/u><\/strong><\/i><\/a>www.foxnews.com\/health<\/u><\/strong><\/i><\/a><\/p>\n

“While some small studies have explored leucovorin as a potential treatment for people with autism, larger controlled clinical trials<\/a> are needed to determine its efficacy and safety. We urge families to consult with their doctors before considering off-label treatments.”<\/p>\n

Dubinsky added that if larger studies confirm leucovorin\u2019s effectiveness, it could become a more accessible treatment for children with autism who may benefit from it.<\/p>\n<\/div>\n

Source – https:\/\/www.foxnews.com\/health\/cancer-drug-could-double-autism-therapy-poised-fda-approval-officials-say <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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