Model May Better Classify Multiple Myeloma and Relapse Risks
A model that may better classify multiple myeloma (MM) using genetic sequence data from hundreds of patients has been developed. The model can identify…
News
Janssen Seeks FDA Approval of Teclistamab for RRMM
Janssen is seeking the approval of its investigational therapy teclistamab in the U.S. for people with relapsed or refractory multiple myeloma (RRMM). “Despite…
Xpovio Conditionally Approved in China for Heavily Treated Patients
China’s National Medical Products Administration (NMPA) has conditionally approved a combination of Xpovio (selinexor) and the corticosteroid dexamethasone to treat adults with relapsed or…
Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma
Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as…
FDA Approves 8th Darzalex Faspro Indication for Myeloma Patients
The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase), in combination with Kyprolis (carfilzomib) and the corticosteroid dexamethasone,…
GC012F, CAR-T Cell Therapy Candidate, Granted FDA Orphan Drug Status
Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA).
1st Patient Enrolled in Phase 1 Trial of Antibody Therapy BHV-1100
Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100. The trial (NCT04634435) seeks…
Optimal Dose of Tasquinimod Found in First Phase of RRMM Trial
The optimal dosing of tasquinimod, Active Biotech’s experimental oral therapy for adults with relapsed or refractory multiple myeloma, has been determined in a…
Blenrep-nirogacestat Combo Moves to Dose-testing Phase 2 of Trial
After promising early results, a sub-study of the DREAMM-5 platform trial is moving forward to its next phase to test a combination of Blenrep…
FDA Expects Decision on Cilta-cel Approval by February 2022
The U.S. Food and Drug Administration (FDA) is expected to decide by the end of February whether or not to approve ciltacabtagene autoleucel, known as…
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