Legend Biotech and The Janssen Pharmaceutical Companies of Johnson & Johnson seek approval to get its Carvykti to more patients
WEST WARWICK, Rhode Island
With its latest FDA filing,Legend Biotech and The Janssen Pharmaceutica; Companies of Johnson & Johnson seeks approval to get its Carvykti to more patients.
After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.
Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy
The companies have high hopes for the drug, pinning its peak sales at $5 billion. Getting there will likely require the treatment to score approval for first-line use. J&J and Legend have already launched their front-line bid, with the phase 3 CARTITUDE-5 trial testing Carvykti’s use following a combination of Velcade, Revlimid and dexamethasone (VRd) in newly diagnosed multiple myeloma patients not intended for transplant.
The Blood Centers of America Advanced Therapies Network is pleased to be doing everything it can to help them get Carvykti to as many patients as possible.