Earlier this year the FDA required six CAR-T drug manufacturers to add secondary cancer warnings to drug labeling, and recommended life-long cancer screenings for patients.
Briefing documents filed ahead of an advisory committee meeting warns about potential side effects of Carvykti and Abecma that emerged during clinical trials, following deaths of myeloma patients.
Observers are waiting to see how the FDA approaches CAR-T therapy safety risks following recently added black box warnings about new cancers.
Genetic sequencing appears to confirm that some cases of cancer have a direct connection to CAR-T cell transgenes used in the medications, the FDA reports.
Cancerous tumors can develop within weeks after receiving CAR-T drug infusions, some of which can be fatal, the FDA warns.
Clinical studies and post-marketing surveillance has linked side effects of Carvykti to a more than 10% increased risk of blood cancer.
Officials are investigating a potential link between certain blood cancer treatments and the development of new, more severe cancers that may result in adverse health outcomes.
