Janssen Pharma's Carvykti Gets Positive CHMP Opinion For Earlier Multiple Myeloma Treatment

(RTTNews) - The Janssen Pharmaceutical Companies of Johnson & Johnson said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has recommended the approval of a Type II variation for carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma or RRMM.

The recommended indication for cilta-cel is for the treatment of adult patients with RRMM, who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment.

Cilta-cel is currently approved under conditional marketing authorisation for the treatment of adults with RRMM, after three prior lines of therapy. The CHMP have now recommended converting the conditional marketing authorisation to a standard marketing authorisation, as the obligations of the conditional approval have now been met.

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