CHMP recommends variation of the indication of Abcema (idecabtagene vicleucel) for r/r multiple myeloma-BMS.
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 Abecma (idecabtagene vicleucel)
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
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 two prior therapies.
For information, the full indications for Abecma will be as follows:"Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy.
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