FDA Mandates 'Boxed Warning' for CAR-T Cancer Therapies

The U.S. health regulator said on Monday companies will be required to add a serious warning on the prescribing information for cancer therapies known as CAR-T, made by Gilead Sciences, Johnson & Johnson, Novartis and others. The other cancer therapies include Bristol Myers Squibb's Breyanzi and its partnered therapy, Areca, with 2seventy bio, J&J unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead unit Kite's Tecartus and Yescarta. Novartis said it will update the prescribing information for its CAR-T cell therapy Kymriah to include instances of T-cell malignancies occurring after treatment with Kymriah.

The Swiss pharmaceutical company said it has not yet confirmed the link between Kymriah and secondary T-cell cancers and remains confident about the treatment and prognosis. Last November, the US Food and Drug Administration (FDA) said it had received reports that patients treated with CAR-T therapy had a type of T. - cell blood cancer. In a letter to the company on Monday, the FDA said it has identified adverse events and clinical trial reports showing abnormalities in T cells since its approval. Health officials said they considered T-cell malignancies, a group of blood diseases that include lymphomas and leukemias that cause hospitalization and death, to apply to all treatments in this section.