WEDNESDAY, Jan. 24, 2024 (Healthday News) — The U.S. Food and Drug Administration has told drugmakers to add a boxed warning to a type of cancer treatment called CAR-T therapy, saying the treatment itself may sometimes cause a secondary cancer. Still, FDA spokesperson Carly Kempler told NBC News that, despite the new warning, “the overall benefits of these products continue to outweigh their potential risks.” Twenty-five reports of rare blood cancers in patients who had gotten CAR-T therapy prompted the agency to add the boxed warning, Kempler said. CAR-T therapy uses a patient’s own immune cells to fight blood cancers such as leukemia, multiple myeloma and lymphoma. Immune cells are harvested from the patient and then genetically altered in a lab to make them target cancer cells. Once tweaked, the immune cells are infused back into the patient. It’s a powerful therapy: In 2022, doctors who had treated two leukemia patients with CAR-T a decade ago reported that the treatment had essentially cured the patients. “This has been a game changer when we think about treating lymphoma and other diseases,” Dr. Matthew Frigault, clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program, told NBC News.  In 2017, the first CAR-T therapy, Novartis’ drug Kymriah, was approved by the FDA. Another five therapies have since been approved. The makers of five of these drugs — Bristol Myers Squibb, for Abecma…  read on >  read on >

Casgevy, a groundbreaking treatment that was approved to treat sickle cell disease in December, was given the U.S. Food and Drug Administration’s blessing on Tuesday to treat another inherited blood disorder. Casgevy is the first CRISPR-based medicine, where gene editing is used to develop the treatment, to be approved for use in the United States. The one-time dose permanently changes DNA in a patient’s blood cells, but experts note the relief will not come cheap. The treatment list price is $2.2 million for its use in both sickle cell disease and beta thalassemia, CNN reported. This latest approval allows Casgevy to be used in patients over the age of 12 with transfusion-dependent beta-thalassemia. With this disorder, the body doesn’t make enough of the oxygen-carrying molecule in blood known as hemoglobin. “Today’s approval is an important step in the advancement of an additional treatment option for individuals with beta-thalassemia, a debilitating disease that places individuals at risk of many serious health problems,” Dr. Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The approval of a cell-based gene therapy for this condition using CRISPR/Cas9 technology reflects FDA’s continued commitment to supporting safe and effective treatments that leverage the most promising and cutting-edge medical technologies,” she added. In December, the FDA approved Casgevy…  read on >  read on >

Scientists from the U.S. Food and Drug Administration conclude in newly released documents that marijuana has less potential for abuse than other drugs with the same restrictions and it should be reclassified as a less dangerous drug. Not only that, the review found there is some evidence backing its use as a medical treatment. Right now, cannabis is classified as a Schedule I controlled substance, a high-risk category that includes heroin and LSD. The move to reconsider the dangers of marijuana first began in 2022, when President Joe Biden asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra and the attorney general to begin reviewing how marijuana is scheduled under federal law. As part of that process, HHS Assistant Secretary for Health Adm. Rachel Levine wrote a letter to the Drug Enforcement Administration (DEA) in August supporting the reclassification of marijuana to a Schedule III drug, a list that includes ketamine, testosterone and Tylenol with codeine. The FDA documents, which were posted online Friday, state that the agency recommends rescheduling marijuana because it meets three criteria: a lower potential for abuse than other Schedule I and II substances; an accepted medical use; and a low or moderate risk of physical dependence in people who abuse it. The National Institute on Drug Abuse backed the recommendation, the documents state. Although marijuana is widely used for recreational purposes,…  read on >  read on >

Women who’ve survived breast cancer may want to up their dietary intake of soy, nuts, beans and whole grains, a new analysis finds. A higher intake of soy compounds called isoflavones was especially tied to better odds that cancer would not return, according to researchers at Johns Hopkins University in Baltimore and elsewhere. The findings can’t yet determine the ideal dosages of isoflavones or other nutrients that appear to prevent recurrence, the authors said, so more research is needed in that area. The study also can’t determine “whether starting to consume them after diagnosis has the same effect as a lifelong dietary habit before diagnosis,” senior study author Dr. Channing Paller said in a Hopkins news release. That’s information that “patients are looking for,” he said. The review of data on nutrition and breast cancer recurrence was conducted by Paller’s group at Johns Hopkins Kimmel Cancer Center, along with researchers at other centers worldwide. Investigators looked at data from 22 major studies that focused on soybeans, lignans (compounds found in a variety of plants such as seeds and nuts), cruciferous vegetables (crunchy veggies like cabbage, broccoli and cauliflower), and green tea. They also looked at the effect of phytonutrients (compounds derived from plants) that are found in these foods. Paller and her colleagues discovered that a high intake of soy isoflavones was linked to a…  read on >  read on >

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the Paris-based company said it’s working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved in the United States. The move was approved by the FDA on Wednesday. Bicillin, a long-acting injectable form of penicillin made by Pfizer that is similar to Extencilline, has been in short supply in the United States since the middle of 2023. It is the recommended treatment for syphilis in adults and it’s the only recommended treatment for pregnant women to prevent syphilis passing from mother to newborn. The National Coalition of STD Directors applauded the FDA’s move. “The delays in treatment that women have faced because of the shortage has placed them and their families at grave risk during the nation’s syphilis crisis,” executive director David Harvey said in a statement. “Today, the administration took meaningful action on our ongoing ask they do anything and everything in their power to address the Bicillin L-A shortage and to provide communities with the resources they need to treat patients and solve this public health crisis.” “We hope this is the first step toward seeing a resolution to…  read on >  read on >