FDA Designates CT103A, CAR T-cell Therapy, an Orphan Drug
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to CT103A, an experimental CAR T-cell therapy that IASO Biotherapeutics and…
News
Xpovio-Kyprolis Combo Shows Good Response in Hard-to-treat Myeloma
Xpovio (selinexor) combined with Kyprolis (carfilzomib) and low-dose dexamethasone leads to strong and durable responses in heavily pretreated multiple myeloma patients, results…
Immune Therapy AO-176 Awarded FDA’s Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Arch Oncology‘s experimental immune-modulating therapy AO-176 as a potential treatment for…
Riney Foundation’s $40M Gift to Further Research at Dana-Farber
The Paula and Rodger Riney Foundation continues to support the Dana-Farber Cancer Institute in its efforts to advance multiple myeloma research, this time…
Japan OKs Abecma as 1st CAR T-cell for Heavily Treated Myeloma
Japan’s Ministry of Health, Labour, and Welfare has approved Abecma (idecabtagene vicleucel) as its first CAR T-cell therapy for adults with relapsed or refractory…
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…
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,…
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