idecabtagene vicleucel

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma

Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 106 CAR T cells) in 128 patients with r/r MM prior treated with 3L therapies including an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab and who are refractory to their last treatment Results: …

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma Read More »

BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma

Shots: The conditional approval is based on the results of the P-II KarMMa study involves assessing Abecma in 122 patients with RRMM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab and who are refractory to their last treatment Results: @median follow-up of 13.3 mos., ORR (74%); CR …

BMS’ Abecma (idecabtagene vicleucel) Receives the Health Canada’s Approval as the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma Read More »

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

Shots: The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable, with a median time to response of …

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma Read More »

BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.