Category: idecabtagene vicleucel

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

Abecma, BMS, Conditional Approval, EC, idecabtagene vicleucel, multiple myeloma, regulatory / August 20, 2021 August 20, 2021

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

Abecma, Anti-BCMA, approval, BMS, CAR T-cell Therapy, Health Canada, idecabtagene vicleucel, Refractory, regulatory, Relapsed / June 1, 2021 June 1, 2021

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

Abecma, approval, bluebird bio, BMS, FDA, idecabtagene vicleucel, multiple myeloma, r/r, Receive, regulatory, US / March 29, 2021 March 29, 2021

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

BioPharma, biopharma nl, bluebird bio, Bristol-Myers Squibb, Cambridge, CAR-T, cell therapy, Daily, idecabtagene vicleucel, Massachusetts, multiple myeloma, New York, SYN, Top Story / July 30, 2020 July 30, 2020

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.