US FDA seeks ‘boxed warning’ for CAR-T cancer therapies

By Gnaneshwar Rajan and Gursimran Mehar

(Reuters) -The U.S. health regulator on Monday asked a host of drugmakers, including Gilead Sciences (NASDAQ:), Johnson & Johnson (NYSE:) and Novartis , to add a serious warning on the label of their cancer therapies that use CAR-T technology.

The other cancer therapies include Bristol Myers (NYSE:) Squibb’s Breyanzi and its partnered therapy, Abecma, with 2seventy bio, J&J unit Janssen and Legend Biotech’s Carvykti, Novartis AG (SIX:)’s Kymriah, and Gilead unit Kite’s Tecartus and Yescarta.

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.

Novartis, and J&J and its partner Legend said the companies will update the prescribing information for their respective CAR-T cell therapies, Kymriah and Carvykti, to include the risk of T-cell malignancies for the therapies.

The Swiss drugmaker said, to date, it has not identified a causal relationship between Kymriah and secondary T-cell malignancies and remains confident in the therapy’s profile.

Novartis shares fell 1% on the Swiss exchange on Tuesday, while J&J’s shares were down 2% on NYSE.

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 CAR-T therapies.Truist Securities analyst Asthika Goonewardene does not expect the safety warnings to hit demand for cancer therapies, but could call into question the technology’s potential use in treating immunity-related diseases.

The FDA said in its letters to the companies on Monday that since the approval, it had identified adverse events and clinical trial reports describing T-cell malignancies. California-based Gilead said it would work with the FDA on the next steps on the product labeling request, adding that its analysis to date had shown no evidence establishing that Yescarta or Tecartus had a causal role in the malignancies.

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 said it was “evaluating next steps on the labels for Abecma and Breyanzi” after receiving the letters.

The company added that it had “not found a causal relationship” between its therapies and the malignancies, with no cases reported in more than 5,000 patients treated with either treatment.

2seventy did not immediately respond to requests for comment.

($1 = 0.8691 Swiss francs)