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New indication for this one-time infusion may provide patients with a treatment-free respite as early as first relapse
Legend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global leader in cell therapy, announced today that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
"The European Commission's approval of CARVYKTI has the potential to transform the treatment paradigm for patients battling multiple myeloma by bringing our novel therapy to them earlier in the course of this incurable disease," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "This approval is a testament to our innovative science and galvanizes our efforts to provide new options that will improve outcomes for patients and give hope to them and their families."
The European approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
The Type-II variation application was submitted to the European Medicines Agency (EMA) by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., a Johnson & Johnson company, Legend Biotech's collaborator for the development and commercialization of CARVYKTI®.
The EC approval follows the U.S. Food and Drug Administration (FDA) approval of CARVYKTI® on April 5th for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI and an IMiD and are refractory to lenalidomide.
Posted In: LEGN
