Janssen Biotech is planning a new Phase 3 clinical trial to explore a combination of under-the-skin daratumumab plus Revlimid (lenalidomide) as a maintenance treatment for…
Myeloma
The Italian Medicines Agency has approved a first-in-human clinical trial testing MolMed’s investigational CAR T-cell product, CD44v6, for the treatment of acute myeloid…
MYELOMA
Janssen Seeks Approval of Darzalex Add-on for Newly Diagnosed Multiple Myeloma Patients in Japan
Janssen has submitted an application to Japanese authorities seeking the approval of Darzalex (daratumumab) — in combination with standard Revlimid (lenalidomide) and dexamethasone — for the treatment of newly diagnosed …
MYELOMA
Investigational Ygalo Shows Promise for Relapsed or Refractory Multiple Myeloma, Interim Data Show
Ygalo (melflufen), a novel compound under investigation for relapsed and refractory multiple myeloma, was well-tolerated and…
New data from a Phase 1 clinical trial show treatment with GlaxoSmithKline‘s investigational antibody-drug conjugate, GSK2857916, was linked to year free of disease progression in…
MYELOMA
OncoTracker Acquires Global Rights to Diagnostic Test, Possible Combo Therapy for Multiple Myeloma
OncoTracker has acquired worldwide rights to a diagnostic test and possible triple combination therapy for patients with multiple myeloma in an agreement with the…
The European Medicines Agency‘s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Celgene‘s Revlimid (lenalidomide) and…
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…
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…
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