Gilead's Tecartus Dropped From FDA List Of CAR-T Therapy With Updated Label Warning Of "Risks Of Secondary Cancer'

Tuesday, the FDA announced to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies. 

“We consider this information to be “new safety information” as defined in section 505-1(b)(3) of the FDCA. Furthermore, we consider the serious risk of T cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.”

In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products. 

In an update, the FDA removed Gilead Sciences Inc’s GILD Tecartus from the list of CAR-T therapies that should have a boxed warning on the risks of secondary cancer after telling five other makers of the drug class to add the warning last week.

The agency wrote safety communications that included warnings saying explicitly that T cell malignancies “have occurred” after treatment with CAR-T therapies. 

In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.

The agency said it’s weighing “the need for regulatory action” in response to clinical testing and safety monitoring reports tied to commercial use. 

The identified risk applies to all approved CAR-T therapies, although the agency noted that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.

The five other CAR-T therapies are Bristol Myers Squibb & Co’s BMY Breyanzi and Abecma, Gilead’s Yescarta, and Novartis AG’s NVS Kymriah, and Johnson & Johnson JNJ / Legend Biotech Corporation’s Carvykti.

Price Action: GILD shares are down 1.13% at $78.59 on the last check Wednesday.

Photo via Wikimedia Commons