CHMP positive for extension of indication for Carvykti (ciltacabtagene autoleucel) to include patients with r/r multiple myeloma who have received at least one prior therapy.- Janssen- Cilag.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Carvykti (ciltacabtagene autoleucel).
The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV
The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy.
Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapies, including an immunomodulatory agent, and a proteasome inhibitor and, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
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