Abecma (idecabtagene vicleucel) in corso di registrazione in EMA come trattamento del mieloma multiplo dopo la 2^ linea

BMS have filed a type II variation for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 antibody and have demonstrated disease progression on the last therapy.

The submission is supported from data from the KarMMa-3 study (results announced 10 Feb 23).

Assuming successful validation of the submission, the variation is being assessed on a 90 day timetable.

• Best Case for EU approval (assuming 1 round of questions, opinion at Day 150) is CHMP opinion 14 Sep 23, EC decision 20 Nov 23
• Base Case for EU Approval (assuming 2 rounds of questions, clock stop at Day 150) CHMP opinion 09 Nov 23, EC decision 15 Jan 24