Articles tagged with: BCMA Targeted Therapies
Press Releases»
Fifth industry collaboration to evaluate nirogacestat as a BCMA potentiator across modalities
Stamford, CT (Press Release) – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the company has entered into a clinical trial collaboration agreement with Pfizer Inc. (NYSE: PFE) to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Pfizer’s anti-B-cell maturation antigen (BCMA) CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma.
Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical …
Press Releases»
- FDA set a target action date of March 27, 2021
- Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma
Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and …
Press Releases»
Increasing BCMA Surface Expression and Reduced Soluble BCMA Levels with Gamma Secretase Inhibitor Nirogacestat May Enhance Clinical Benefit in Combination with PBCAR269A, an Allogeneic BCMA-Targeted CAR T Cell Product
Durham, NC and Stamford, CT (Press Release) – Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced they have entered into a clinical trial collaboration agreement. Per the agreement, PBCAR269A, Precision BioSciences’ wholly-owned investigational allogeneic chimeric antigen receptor (CAR) T cell therapy candidate targeting B-cell maturation antigen (BCMA), will be evaluated in combination …
Press Releases»
Third collaboration to evaluate nirogacestat in combination with BCMA therapies across modalities
Stamford, CT (Press Release) – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the company has entered into a clinical collaboration and supply agreement with Janssen Biotech, Inc. (Janssen) to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Janssen’s bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, teclistamab, in patients with relapsed or refractory multiple myeloma.
Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma …
Press Releases»

Durham, NC (Press Release) – Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PBCAR269A for the treatment of relapsed / refractory multiple myeloma. This is the company’s second allogeneic chimeric antigen receptor (CAR T) cell therapy to receive Fast Tack Designation for which the FDA previously granted Orphan Drug Designation.
“Fast Track Designation will help us expedite our allogeneic CAR T cell therapy program …
Press Releases»
- BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved in the European Union
- Marketing authorisation follows the recent US approval of BLENREP
London, United Kingdom (Press Release) – GlaxoSmithKline plc today announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose …
Press Releases»
- BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody
- BLENREP is the fifth major medicine approval for GSK in 2020
London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in …