By Pratik Jain
(Reuters) – The U.S. Food and Drug Administration (FDA) said on Tuesday it was investigating cancer therapies made by companies such as Gilead Sciences and Johnson & Johnson over the risk of hospitalizations and death due to a serious safety issue.
The FDA said it had received reports of T-cell malignancies, which refer to a group of blood disorders including lymphomas and leukemias, after treatment with CAR-T therapies or chimeric antigen receptor T-cell therapies.
Approved cancer therapies in this class 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’s Kymriah, and Gilead’s unit Kite’s Tecartus and Yescarta are also a part of the investigation.
Shares of Gilead were down marginally, while Legend’s stock fell 4.2% in afternoon trading. Autolus Therapeutics, which is also developing CAR-T therapies, was down nearly 12%.
RBC analysts said in a note they believed that the concerns could be higher for Novartis’ Kymriah, and extremely rare for all the other marketed CAR-Ts.
Gilead said it had cooperated with the FDA on its request for an analysis of the company’s data, adding there was no evidence that treatment with either of its two therapies had a causal role in the development of new malignancies.
“We are confident in the overall safety profile of both Tecartus and Yescarta,” Gilead told Reuters in an emailed statement.
CAR-T therapies, or chimeric antigen receptor T-cell therapies, generally involve extracting disease-fighting T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body.
J&J, Bristol Myers and Novartis did not immediately respond to Reuters’ requests for comment.
Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies, the FDA said.
(Reporting by Pratik Jain in Bengaluru and Michael Erman in New York; Editing by Krishna Chandra Eluri and Maju Samuel)
