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.
U.S. FDA Approves Abecma for Relapsed or Refractory Multiple Myeloma
Approvals, B-cell maturation antigen (BCMA), Bristol Myers Squibb, CAR-T Therapy, Clinical Trials, Cytokine Release Syndrome (CRS), FDA/Regulatory, First-In-Class, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Proteasome Inhibitors, R&D, Relapse/Refractory Multiple Myeloma, TherapeuticsThe 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.
FDA Approves Oncopeptides’ Pepaxto for Triple-Class Refractory Multiple Myeloma
Approvals, Brands, Clinical Trials, Dexamethasone, FDA, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Product Launches, Proteasome Inhibitors, R&D, Steroids, Therapeutics, Triple-Class Refractory Multiple MyelomaThe U.S. Food and Drug Administration approved Oncopeptides AB’s Pepaxto (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
The U.S. Food and Drug Administration approved Karyopharm Therapeutics Inc.’s Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Can Janssen Cure Cancer? Company’s 80+ ASH Presentations Suggest It’s On Right Track
American Society of Hematology (ASH) Annual Meeting, B-cell maturation antigen (BCMA), Cancer, Clinical Data, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, Hematology, Janssen, Johnson & Johnson, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, TherapeuticsThe 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.
Denmark-based Genmab A/S announced positive topline data from the second part of the Phase III CASSIOPEIA trial evaluating daratumumab (marketed as Darzalex) monotherapy as maintenance treatment compared to observation for patients with newly diagnosed multiple myeloma that are eligible for autologous stem cell transplant.
Genmab is squaring off with Janssen in a legal battle over royalties from the multiple myeloma drug Darzalex, and shares of the Denmark-based company fell in trading after the announcement.
Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston
Allogeneic Cells, Boston, Business, Cell Therapy, Clinical Data, Clinical Trials, Facilities/Sites/Manufacturing, Immuno-oncology, Massachusetts, Multiple myeloma, Oncology, Product Pipeline, Progression-Free Survival (PFS), Protease inhibitors, R&D, R&DTakeda Pharmaceutical opened a new 24,000-square-foot R&D cell therapy manufacturing facility in Boston at the site of the company’s R&D headquarters.