EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy

The European Medicines Agency's CHMP recommended conditional approval of Janssen, a unit of Johnson & Johnson JNJ, and its partner Legend Biotech Corporation's LEGN CAR-T therapy to treat multiple myeloma.

• The drug, Carvykti (ciltacabtagene autoleucel) belongs to a class of drugs known as CAR-T therapies or chimeric antigen receptor T-cell therapies. 
• The therapy involves extracting disease-fighting T-cells from a patient, re-engineering them to attack cancer, and infusing them back into the body.
• The drug now needs the approval of the European Commission, which has the final word on market access.
• Data from the ongoing pivotal CARTITUDE-1 study supported the positive CHMP opinion. 
• Two-year follow-up results were presented at the American Society of Hematology (ASH) 2021 Annual Meeting.
• About 84% of patients enrolled in the study responded to the treatment with a durable response. Around 69% showed a complete response.
• The CHMP Opinion follows the FDA approval of cilta-cel last month.
• Price Action: LEGN shares are down 5.07% at $36.88 during the market session on the last check Friday.