NEW YORK – Janssen on Thursday said it submitted a type II variation application to the European Medicines Agency seeking approval for Carvykti (ciltacabtagene autoleucel) as a treatment for patients with relapsed and refractory multiple myeloma.
If approved, the autologous B-cell maturation antigen-targeting CAR T-cell therapy could be available as an earlier, second-line therapy for advanced multiple myeloma. Janssen's application is based on data from the CARTITUDE-4 Phase III trial, in which patients who had relapsed on one to three lines of prior therapy and become refractory to Bristol Myers Squibb's Revlimid (lenalidomide) received Carvykti or one of two combination regimens: Celgene's Pomalyst (pomalidomide), Takeda/Janssen's Velcade (bortezomib), and dexamethasone; or Genmab's Darzalex (daratumumab), Pomalyst, and dexamethasone.
Earlier this year, Janssen and codevelopment partner Legend said they were unblinding the CARTITUDE-4 trial because it met its primary endpoint and showed that Carvykti-treated patients had significantly better progression-free survival compared to patients on the comparator treatments. Janssen will present detailed results from the study at the American Society of Clinical Oncology's annual meeting on June 5.
"The previous European Commission approval recognized the potential for [Carvykti] to positively impact outcomes for people living with relapsed and refractory multiple myeloma," Edmond Chan, senior director of the Europe, Middle East, and Africa hematology therapeutic division at Janssen-Cilag, said in a statement. "Today's submission to the EMA is an important step towards helping patients benefit from this CAR T therapy earlier in their treatment journey. If approved, this will be the first and only CAR T therapy available to treat relapsed and refractory patients as early as second line."