FDA Updates Gilead's Tecartus Label with Revised Boxed Warning on Potential Secondary Cancer Risk

On January 24, Gilead's Tecartus received a slight easing from the list of black box warnings related to the risk of T-cell malignancies associated with cell therapy.

Following the FDA's safety investigation into CAR-T therapies, it was found that the CAR-T cell treatment products targeting BCMA or CD19, which have been approved for marketing — Yescarta, Tecartus, Kymriah, Breyanzi, Abecma, and Carvykti — all pose a serious risk of T-cell malignancy.

Thus, the FDA sent letters to Gilead, Johnson & Johnson, Novartis, and BMS last Friday, requiring them to add a black box warning on product labels to alert patients and prescribers about the potential risk of T-cell malignancies, with serious consequences including hospitalization and death.

As of the issuance of the January 19 letter, these companies have 30 days to submit supplementary materials and make modifications to the approved labels of their respective products.

However, the FDA recently revised the wording regarding this therapy, and Tecartus finally breathed a sigh of relief. In its response letter, the FDA noted that while T-cell malignancies have been reported following treatment with BCMA or CD19 targeted CAR-T therapies, for Tecartus, such adverse events are only "possible." The phrase "including Tecartus" was also removed. The amendment has a 30-day response period.

Notably, this letter supersedes the FDA's response letter dated January 19. In Tuesday’s reply to Kite Pharma, a subsidiary of Gilead Sciences, the FDA stated: "For Tecartus, the new label should include updated safety information, specifically that Tecartus may potentially increase the risk of cancer.”

References:

https://endpts.com/fda-updates-gileads-label-for-car-t-tecartus-with-new-boxed-warning-for-secondary-cancer/