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.
FDA Approves Oncopeptides’ Pepaxto for Triple-Class Refractory Multiple MyelomaApprovals, Brands, Clinical Trials, Dexamethasone, FDA, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Product Launches, Proteasome Inhibitors, R&D, Steroids, Therapeutics, Triple-Class Refractory Multiple Myeloma
The 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.
Merck acquired Maryland-based OncoImmune and the Covid-19 therapeutic candidate CD24Fc for $425 million in upfront cash two months after the Phase III asset demonstrated efficacy during an interim analysis.
Shares of Karyopharm Therapeutics climbed in trading after the company announced positive topline results in a Phase III study of Xpovio (selinexor) in patients with advanced unresectable dedifferentiated liposarcoma, which sets up potential approval in this indication.
GSK’s blood cancer drug wins European panel thumbs-upAntibody-Drug Conjugates (ADCs), B-cell maturation antigen (BCMA), Blockbusters, Blood Cancers, Cells, Chemotherapy, European Medicines Agency, FDA/Regulatory, Immunomodulatory Agents, Recommended For Approval, Relapse/Refractory Multiple Myeloma
A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.
The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.
Two Roche drugs were placed on partial clinical hold as the U.S. FDA continues to examine potential dangers of checkpoint inhibitors following deaths associated with Merck’s Keytruda.
The U.S. FDA placed a partial clinical hold on five of Celgene Corporation’s clinical trials and a full clinical hold on one of the company’s clinical trials in its FUSION program.
DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple MyelomaAccelerated Drug Approvals, Approvals, Biotech, Biotechnology, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Clinical Trials, FDA/Regulatory, First-In-Class, Health, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Immunotherapy, Launches, Monoclonal Antibodies, Monoclonal Antibodies, Multiple Myeloma, Multiple Myeloma, Multiple Myeloma, New Drug Approvals, Priority Review, Priority Review, Product Launches, Proteasome Inhibitors, R&D
First-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who […]