NEW BRUNSWICK (dpa-AFX) - 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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