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 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.
The 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.
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.
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.
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 risk 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.
Gilead Sciences, Johnson & Johnson, Novartis, Bristol Myers Squibb, 2seventy bio and Legend Biotech did not immediately respond to Reuters' request for comments.
(Reporting by Gnaneshwar Rajan in Bengaluru; Editing by Sherry Jacob-Phillips)
