Carvykti (ciltacabtagene autoleucel): positive CHMP opinion for extension indication in 2L treatment of adult patients with relapsed and refractory multiple myeloma
On 22 February 2024, 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.
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.
For information, the full indications for Carvykti will be as follows:
Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent, and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.