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EMA's CHMP Recommends Janssen, Legend Biotech's Carvykti in Earlier-Line Multiple Myeloma

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that regulators approve Janssen and Legend Biotech's Carvykti (ciltacabtagene autoleucel) as a second-line treatment for relapsed or refractory multiple myeloma patients.

The committee specifically recommended approval for the B-cell maturation antigen (BCMA)-directed CAR T-cell therapy for patients who have received an immunomodulatory agent and a proteasome inhibitor and whose cancers are refractory to Bristol Myers Squibb's immunomodulatory agent Revlimid (lenalidomide). The European Commission will now review the CHMP's recommendation and decide whether to make this indication available to patients in the EU.

CHMP based its recommendation on the results of the Phase III CARTITUDE-4 clinical trial in which Carvykti benefited patients versus a treatment regimen containing either BMS's Pomalyst (pomalidomide), bortezomib, and dexamethasone (PVd) or Janssen's Darzalex (daratumumab), Pomalyst, and dexamethasone (DPd). Patients enrolled in CARTITUDE-4 had to have received between one and three prior lines of therapy.

The autologous CAR T-cell therapy, which Janssen and Legend jointly developed, was already conditionally approved in Europe as a fourth- or later-line treatment for multiple myeloma. In addition to CHMP recommending approval in an earlier-line setting, Janssen and Legend said on Friday that the committee has also recommended converting Carvykti's conditional approval to a standard marketing authorization, "as the obligations of the conditional approval have now been met."

In the US, Carvykti is approved as a fifth- or later-line treatment for multiple myeloma patients, and although it has filed a supplemental biologics application with the US Food and Drug Administration seeking approval for the cell therapy in an earlier-line setting, the agency hasn't issued a decision.

On March 15, the Oncologic Drugs Advisory Committee (ODAC) to the FDA will meet to discuss the data supporting Carvykti as a second-line treatment. On the same day, the ODAC will also discuss data supporting BMS's competing BCMA-directed CAR T-cell therapy, Abecma (idecabtagene vicleucel), in earlier-line treatment settings. Meanwhile, last month, EMA's CHMP also recommended approval for Abecma in earlier-line multiple myeloma.