Tag: belantamab mafodotin

Two FDA-approved antibody-drug conjugates (ADCs)—gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth) and belantamab mafodotin (Blenrep®; GSK)—were withdrawn from the U.S. market after confirmatory trials failed to verify...

The US Food and Drug Administration (FDA) has approved belantamab mafodotin (Blenrep®' GSK; see ADC Drugmap), an antibody-drug conjugate (ADC) comprising a humanized BCMA...

Belantamab mafodotin (Blenrep®; GSK), a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, has been approved in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile at the proposed dosage of belantamab mafodotin (Blenrep®; GSK) combinations for the treatment of patients diagnosed with multiple myeloma.

US Food and Drug Administration (FDA) has accepted GSK's new Biologics License Application (BLA) for belantamab mafodotin (Blenrep®; GSK) in combinations with bortezomib plus...

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy Designation (BTD) for belantamab mafodotin (Blenrep®; GSK) combined with bortezomib plus dexamethasone (BorDex) for the treatment of relapsed or refractory multiple myeloma.*

The treatment patients diagnosed with relapsed or relapsed/refractory multiple myeloma (RRMM), those who have relapsed or who are refractory to at least 1 line of...

Multiple myeloma is the second most common hematological malignancy in the United States and is generally considered treatable, but not curable. Multiple myeloma...

As we plan ahead, for the upcoming digital World ADC Europe with much greater confidence, we were reflecting on what a year it has...

The European Commission has granted conditional marketing authorization* for the use of GlaxoSmithKline's anti-B-cell maturation antigen (BCMA) therapy belantamab mafodotin (Blenrep®) as monotherapy for...