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.
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Posted In: BiotechNewsHealth CareMoversTrading IdeasGeneralBriefsEuropean Medicines Agencymultiple myeloma
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