The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
AbbVie exercised an exclusive right to acquire TeneoOne, an affiliate of TeneoBio, and the company’s lead asset TNB-383B for relapsed or refractory multiple myeloma (R/R MM).
The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
The Janssen Pharmaceutical Companies of Johnson & Johnson has a presence in more than 80 of the hematology studies presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in December.
BioSpace reviewed the third-quarter 2020 financial announcements from some of the biopharma industry’s leading players.
South San Francisco-based Allogene Therapeutics released some early data from the company’s UNIVERSAL clinical trial of ALLO-715 for relapsed/refractory multiple myeloma.
Celyad Oncology is at the forefront of cutting-edge immunotherapy and is hopeful of providing a new way forward for patients with relapsed/refractory multiple myeloma.
The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.