Carvykti is intended to treat adults with relapsed or refractory multiple myeloma who have previously received a minimum of one line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.
Janssen’s sBLA is supported by findings from the Phase III CARTITUDE-4 study of Carvykti.
This first randomised study has been designed to assess the safety and efficacy of the therapy versus daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd) to treat patients with relapsed or lenalidomide-refractory multiple myeloma.
Janssen Research & Development Oncology Global Therapeutic Area head Peter Lebowitz said: “We are focused on advancing Carvykti in the treatment of multiple myeloma, including for patients with relapsed or refractory disease, where we hope to intervene earlier with the goal of transforming outcomes for patients.
“We look forward to collaborating with the FDA on the review of this application and continuing to bring Carvykti to patients who are candidates for this CAR-T therapy.”
In February last year, the BCMA-directed, genetically modified autologous T-cell immunotherapy received approval from the US Food and Drug Administration to treat adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Janssen Biotech signed an exclusive global license and collaboration agreement with Legend Biotech USA in December 2017 for the development and commercialisation of Carvykti.