{"id":23024,"date":"2024-01-24T01:21:02","date_gmt":"2024-01-24T07:21:02","guid":{"rendered":"https:\/\/ustower.net\/?p=23024"},"modified":"2024-01-24T01:21:07","modified_gmt":"2024-01-24T07:21:07","slug":"fda-says-cancer-treatment-car-t-therapy-may-increase-risk-of-cancer","status":"publish","type":"post","link":"https:\/\/ustower.net\/?p=23024","title":{"rendered":"FDA says cancer treatment CAR-T therapy may increase risk of cancer"},"content":{"rendered":"\n

The Food and Drug Administration this week told several drugmakers<\/a> to add a boxed warning \u2014 the agency\u2019s strongest safety label \u2014 to the prescribing information for a type of cancer treatment called CAR-T therapy<\/a>, saying the treatment itself may increase a person\u2019s risk of cancer.<\/p>\n\n\n\n

Carly Kempler, a spokesperson for the FDA, said that, despite the warning, “the overall benefits of these products continue to outweigh their potential risks.”<\/p>\n\n\n\n

The agency\u2019s decision to update the labels was based on reports <\/strong>of rare blood cancers in patients who had previously gotten CAR-T therapy, Kempler said. As of Monday, the agency had received 25 reports of the blood cancers in CAR-T patients, she said.<\/p>\n\n\n\n

Bruce Levine, a professor in cancer gene therapy at the University of Pennsylvania, said that in addition to the reports submitted to the FDA, two abstracts published late last year<\/a> in the journal Blood also cited a potential cancer risk associated with CAR-T therapy, which likely \u201cforced the FDA\u2019s hand.\u201d<\/p>\n\n\n\n

CAR-T \u2014 or chimeric antigen receptor T cell \u2014 therapy uses a patient\u2019s own immune cells<\/a> to treat certain blood cancers, such as leukemia, multiple myeloma and lymphoma. It involves harvesting the immune cells \u2014 in this case, T cells \u2014 then genetically altering them in a lab to make them target cancer cells, and finally reinfusing them back into the patient.<\/p>\n\n\n\n

It\u2019s proven to be highly effective in hard-to-treat cases, experts said. In 2022, doctors who had treated two leukemia patients with CAR-T a decade ago said it was fair to say the therapy had cured the patients of the disease<\/a>.<\/p>\n\n\n\n

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

The first CAR-T therapy<\/a>, Novartis\u2019 drug Kymriah, received FDA approval in 2017. Since then, another five have been approved.<\/p>\n\n\n\n

The makers of five of the drugs \u2014 Bristol Myers Squibb, for Abecma and Breyanzi; Gilead Sciences’ Kite Pharma, for Yescarta; Johnson & Johnson’s Carvykti; and Novartis, for Kymriah \u2014 received letters from the FDA, stating that they must submit proposed label changes in the next 30 days to note that, in rare cases, CAR-T therapy can increase the risk of rare blood cancers. (Kite Pharma did not receive a letter about the sixth CAR-T drug, Tecartus.)<\/p>\n\n\n\n

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

In a statement to NBC News, a spokesperson for Novartis said the company has not found \u201csufficient evidence\u201d to support a link between cancer and its treatment, which has been used in more than 10,000 patients. However, the spokesperson said, the company will work with the FDA to update its label \u201cappropriately.\u201d<\/p>\n\n\n\n

Spokespersons for Johnson & Johnson and Gilead Sciences also said the drugmakers would work with the agency to update their labels.<\/p>\n\n\n\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\n\n\n

\u201cPatient safety is our top priority,\u201d the spokesperson said. <\/p>\n\n\n\n

How might CAR-T therapy cause cancer?<\/strong><\/strong><\/h2>\n\n\n\n

Still, there\u2019s the question of how CAR-T could cause cancer \u2014 if it does at all.<\/p>\n\n\n\n

\u201cWe actually don\u2019t know whether this is casual, meaning, we don\u2019t know for a fact that the CAR-T cells in the tumor have led to this,\u201d said Frigault, of Mass General. <\/p>\n\n\n\n

CAR-T treatments are still relatively new: Frigault noted that the FDA has required<\/a> that the makers of the products conduct 15-year follow-up studies to assess the potential risk of secondary cancers following treatment. (Secondary cancers are cancers that can arise from treatment.) <\/p>\n\n\n\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,\u201d he said, \u201cbut more that there may be an association.\u201d<\/p>\n\n\n\n

\u201cThis is what the FDA does. They look for a signal,\u201d he added.<\/p>\n\n\n\n

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

More than 27,000 doses of CAR-T therapy have been administered in the U.S., according to the FDA.<\/p>\n\n\n\n

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

Dr. Saad Usmani, a myeloma physician and cell therapist at Memorial Sloan Kettering, said the label change should support physicians\u2019 current practice of discussing with patients the risk of developing secondary cancers following cancer treatment. <\/p>\n\n\n\n

Usmani noted that other cancer treatments, such as radiation and chemotherapy, also carry a risk of secondary cancers.<\/p>\n\n\n\n

\u201cThe change is expected given the recent reports, albeit very low incidence in such cases,\u201d he said.  <\/p>\n\n\n\n

Dr. Marcela Maus, an associate professor of medicine at Harvard Medical School and director of the Cellular Immunotherapy Program at Massachusetts General Hospital, said physicians might be more cautious, but it most likely won\u2019t change much in their practice.<\/p>\n\n\n\n

\u201cWe need to manage the cancer that they have now, so I don\u2019t imagine it being massively different,\u201d she said.<\/p>\n\n\n\n

Nbcnews<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The Food and Drug Administration this week told several drugmakers to add a boxed warning \u2014 the agency\u2019s strongest safety label \u2014 to the prescribing information for a type of cancer treatment called CAR-T therapy, saying the treatment itself may increase a person\u2019s risk of cancer. Carly Kempler, a spokesperson for the FDA, said that, despite the warning, […]<\/p>\n","protected":false},"author":5,"featured_media":23025,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5784],"tags":[26115,8138,26116,3043,26119,26118,26117],"class_list":["post-23024","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health","tag-cancer-risk","tag-cancer-treatment","tag-car-t-therapy","tag-fda","tag-pharmaceutical-manufacturers","tag-prescribing-information","tag-rare-blood-cancers"],"_links":{"self":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/23024","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=23024"}],"version-history":[{"count":1,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/23024\/revisions"}],"predecessor-version":[{"id":23026,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/23024\/revisions\/23026"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/media\/23025"}],"wp:attachment":[{"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=23024"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=23024"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=23024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}