The FDA Oncologic Drugs Advisory Committee voted overwhelmingly in favor of expanding the indications of two chimeric antigen receptor engineered T-cell therapies for multiple myeloma that showed improvement in progression-free survival, but also reported a higher number of early deaths on the experimental arm.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
