(Reuters) -The U.S. health regulator said on Monday companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others.
The other cancer therapies include Bristol Myers Squibb’s Breyanzi and its partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG Kymriah, and Gilead unit Kite’s Tecartus and Yescarta.
Last November, the U.S Food and Drug Administration said it had received reports of patients developing a type of T-cell blood cancer after being treated with genetically modified cells known as chimeric antigen receptor T-cell therapies or CAR-T.
The FDA said in its letters to the companies on Monday that since the approval of the therapies, it had identified adverse events and clinical trial reports describing T-cell malignancies following the treatment.
The health regulator said it considered the risks of T-cell malignancy, which refers to a group of blood disorders including lymphoma and leukemia, resulting in hospitalization and death, to be applicable to all therapies in the category.
Bristol Myers Squibb confirmed in an emailed statement about the FDA’s letters, and said it is “evaluating next steps on the labels for Abecma and Breyanzi”.
“To date, BMS has not observed any CAR-positive T-cell malignancy cases.”
The so-called boxed warnings are the strictest warnings issued by the FDA regarding the potential serious side effect from the use of a drug.
The CAR-T treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.
Since 2017, six CAR-T cell therapies have been approved by the FDA, and all are for the treatment of blood cancers, including lymphoma and some forms of leukemia.
Gilead Sciences, Johnson & Johnson, Novartis, 2seventy bio and Legend Biotech did not immediately respond to Reuters’ request for comments.
(Reporting by Gnaneshwar Rajan, Gursimran Kaur in Bengaluru, Additional reporting by Shubhendu Deshmukh; Editing by Sherry Jacob-Phillips)
Comments