Managed Healthcare Executive April 6, 2024
The decision comes after the FDA Oncologic Drugs Advisory Committee provided a unanimous vote recommending approval. Carvykti is now available to treat patients after just one prior line of therapy.
Carvykti (ciltacabtagene autoleucel) has gained FDA approval to treat patients with multiple myeloma (MM) earlier. The chimeric antigen receptor (CAR) T-cell therapy from Janssen/Johnson & Johnson will now be available for patients who have received just one prior line of therapy. The company submitted the supplemental biologics license application in June 2023.
The approval comes after the FDA Oncologic Drugs Advisory Committee (ODAC) unanimously voted to recommend Carvykti for approval. ODAC reviews and evaluates the safety and efficacy of drugs at the FDA’s request, but the committee’s recommendations are non-binding.
...Today's Sponsors
Today's Sponsor