{"id":494618,"date":"2024-01-24T08:32:32","date_gmt":"2024-01-24T13:32:32","guid":{"rendered":"https:\/\/platohealth.ai\/fda-warns-of-rare-secondary-cancer-risk-with-car-t-therapies-drugs-com-mednews\/"},"modified":"2024-01-24T10:02:52","modified_gmt":"2024-01-24T15:02:52","slug":"fda-warns-of-rare-secondary-cancer-risk-with-car-t-therapies-drugs-com-mednews","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-warns-of-rare-secondary-cancer-risk-with-car-t-therapies-drugs-com-mednews\/","title":{"rendered":"FDA Warns of Rare Secondary Cancer Risk With CAR-T Therapies – Drugs.com MedNews","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

Medically reviewed<\/a> by Drugs.com.<\/span><\/p>\n

By Robin Foster HealthDay Reporter<\/p>\n

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.<\/p>\n

Still, FDA spokesperson Carly Kempler<\/a> told NBC News<\/em> that, despite the new warning, “the overall benefits of these products continue to outweigh their potential risks.”<\/p>\n

Twenty-five reports <\/strong>of rare blood cancers in patients who had gotten CAR-T therapy prompted the agency to add the boxed warning<\/a>, Kempler said. <\/p>\n

CAR-T therapy uses a patient\u2019s 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.<\/p>\n

It\u2019s a powerful therapy: In 2022, doctors who had treated two leukemia patients with CAR-T a decade ago reported<\/a> that the treatment had essentially cured the patients.<\/p>\n

\u201cThis has been a game changer when we think about treating lymphoma and other diseases,\u201d Dr. Matthew Frigault<\/a>, clinical director of the Massachusetts General Hospital Cellular Immunotherapy Program, told NBC News<\/em>. <\/p>\n

In 2017, the first CAR-T therapy, Novartis\u2019 drug Kymriah<\/a>, was approved by the FDA. Another five therapies have since been approved.<\/p>\n

The makers of five of these drugs — Bristol Myers Squibb, for Abecma and Breyanzi; Gilead Sciences’ Kite Pharma, for Yescarta; Johnson & Johnson’s Carvykti; and Novartis, for Kymriah — must submit proposed label changes in the next 30 days to note that CAR-T therapy can raise the risk of rare blood cancers, the FDA said.<\/p>\n

If the drugmakers disagree, they can submit a rebuttal explaining why a change isn\u2019t needed, NBC News<\/em> reported.<\/p>\n

In a statement, a spokesperson for Novartis said the company has not found \u201csufficient evidence\u201d to support a link between cancer and its treatment. However, the company will work with the FDA to update its label \u201cappropriately,\u201d the spokesman said.<\/p>\n

Spokespersons for Johnson & Johnson and Gilead Sciences also told NBC News<\/em> that they would work with the agency to update their labels.<\/p>\n

A spokesperson for Bristol Myers Squibb said the company is evaluating \u201cnext steps\u201d following the FDA\u2019s notice, although it has not seen any cancer cases associated with its treatment.<\/p>\n

CAR-T treatments are still relatively new, Frigault noted, so the FDA has required<\/a> the makers of these therapies to conduct 15-year follow-up studies to measure the potential risk of secondary cancers.<\/p>\n

The FDA \u201cis not saying that every single one of the cases they\u2019ve reported has clearly shown CAR-T has led to this, but more that there may be an association,” he said. “This is what the FDA does. They look for a signal.”<\/p>\n

If CAR-T does cause cancer, the risk is likely very small, Dr. Hemant Murthy<\/a>, a hematology-oncology physician at the Mayo Clinic in Florida, told NBC News.<\/em><\/p>\n

\u201cI don\u2019t really see this affecting too much of practice,\u201d Murthy said.<\/p>\n

Dr. Saad Usmani<\/a>, a myeloma physician and cell therapist at Memorial Sloan Kettering, noted that other cancer treatments, such as radiation and chemotherapy, also carry a risk of secondary cancers.<\/p>\n

\u201cThe [boxed warning] change is expected given the recent reports, albeit very low incidence in such cases,\u201d he told NBC News<\/em>. <\/p>\n

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Sources<\/h2>\n