The U.S. Food and Drug Administration (FDA) has approved a label update for Legend Biotech (NASDAQ:LEGN) and Johnson & Johnson (NYSE:JNJ) unit Janssen’s multiple myeloma treatment Carvykti to include a warning about the occurrence of blood cancer following treatment with the drug. The move from the FDA comes weeks after the regulator said it was looking into reports of T-cell malignancies in patients who have been treated with CAR-T cell therapies such as Carvykti. U.S.-listed shares of Legend Biotech (LEGN) on Friday fell as much as 4.9% to a session low at $57.1. The stock had recouped those losses by afternoon and was now up 0.3%. Meanwhile, J&J (JNJ) stock was slightly higher. “In this label update, the following sentence is added to the Boxed Warning of the U.S. Prescribing Information: ‘Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred following treatment with Carvykti,” Legend (LEGN) said in a regulatory filing on Thursday. The update to the boxed warning comes after additional efficacy and safety information from longer-term follow-up of Legend’s (LEGN) mid-stage trial called Cartitude-1. The information showed that blood malignancies occurred in 10% of the 97 patients who received treatment with Carvykti in the Cartitude-1 study. Nine of those ten patients died following the development of myeloid neoplasms. Legend (LEGN) added that “a potential underlying mechanism between Carvykti and the development of myeloid neoplasms has not been established.” According to the company, more than 2K patients till date have been treated with cilta-cel in clinical and commercial settings. More on Legend Biotech, Johnson & Johnson Legend Biotech: Carvykti Is Sailing High, But Watch The Horizon Legend Biotech GAAP EPS of -$0.17 beats by $0.14, revenue of $96.01M misses by $3.5M Johnson & Johnson Vs. Pfizer: Better Pharma Stock? Johnson & Johnson: Sleep Well At Night With The Only AAA-Rated Dividend Aristocrat J&J submits sBLA to FDA for Rybrevant combo in non-small cell lung cancer
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