FDA Delays Decision on Selinexor’s Approval for Heavily Treated Multiple Myeloma
The U.S. Food and Drug Administration is delaying its decision on a new drug application (NDA) seeking approval of selinexor in combination with dexamethasone…
Myeloma
FDA Application Submitted for Darzalex Combo Therapy to Treat Certain Multiple Myeloma Patients
An application has been submitted seeking U.S. approval of Darzalex (daratumumab) in combination with standard pre-transplant therapy to treat newly diagnosed multiple myeloma patients…
FDA Puts Partial Hold on Venetoclax’s Multiple Myeloma Trials
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on venetoclax’s multiple myeloma trials after new safety concerns were raised during…
Phase 1/2 Trial of Tinostamustine Recruiting Patients with Myeloma, Other Blood Cancers
The expansion part of a Phase 1/2 clinical trial testing tinostamustine in relapsed or refractory blood cancers has begun treating the first patient. The trial…
Darzalex Triple Combo Approved in England for Difficult-to-treat Multiple Myeloma
A triple combination of Darzalex (daratumumab), Velcade (bortezomib), and dexamethasone will be available on the National Health Service (NHS) in England for…
Janssen Seeks Final FDA Approval for Darzalex Combo Therapy for Newly Diagnosed Multiple Myeloma
Janssen has is seeking approval from the U.S. Food and Drug Administration (FDA) for Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and…
NantKwest, ProMab Partner to Develop Natural Killer Cell Therapy for Multiple Myeloma, Other Blood Cancers
NantKwest and ProMab Biotechnologies are collaborating to develop a novel immunotherapy for multiple myeloma using natural killer (NK) cells that target the B-cell maturation…
Kyprolis Combo Yields Positive Results as Initial Treatment for Multiple Myeloma
A combination of Kyprolis (carfilzomib) and dexamethasone, already approved for relapsed and refractory multiple myeloma,…
CARsgen to Begin CT053 Clinical Testing in China for Heavily Treated Myeloma Patients
CT053, one of CARsgen Therapeutics‘ lead CAR T-cell therapies, soon will begin clinical testing in China for the treatment of patients with relapsed…
Under-the-skin Formulation as Effective as Intravenous Darzalex for Myeloma Patients, Study Says
An under-the-skin injection of daratumumab is as effective as its intravenous formulation, Darzalex (daratumumab), at reducing tumor burden in multiple myeloma patients, a Phase 3…
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