Tag: Multiple myeloma
From Withdrawal to Reapproval – Lessons From Gemtuzumab ozogamicin and Belantamab...
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conjugates (ADCs)—gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth) and belantamab mafodotin (Blenrep®; GSK)—were withdrawn from the U.S. market after confirmatory trials failed to verify...
Belantamab mafodotin Combinations Approved in EU for Treatment of Relapsed/refractory Multiple...
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
Belantamab Mafodotin Combinations Accepted for US FDA Review in R/R Multiple...
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...
Belantamab Mafodotin + Bortezomib plus Dexamethasone Receives Breakthrough Therapy Designation in...
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.*
Belantamab Mafodotin to be Withdrawn from US-market
GSK has initiated the process for withdrawal of belantamab mafodotin-blmf (Blenrep®) from the US market. The withdrawal of the US marketing authorization follows the request of the US Food and Drug Administration (FDA).
ASH 2020: Potential of Belantamab Mafodotin in Combination Standard Therapies in...
Multiple myeloma is the second most common hematological malignancy in the United States and is generally considered treatable, but not curable. Multiple myeloma...
European Commission Grants Conditional Marketing Authorization to GSK for the Use...
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...
U.S. FDA Approves Belantamab Mafodotin as a Monotherapy in R/R Multiple...
The U.S. Food and Drug Administration has approved* belantamab mafodotin-blmf (Blenrep®; GlaxoSmithKline/GSK) as a monotherapy treatment for adult patients with relapsed or refractory multiple...
ASCO 2020 – Advancing Antibody-drug Conjugates: Belantamab Mafodotin
Multiple myeloma is the third most common blood cancer and is generally considered treatable, but not curable. Research into new therapies is needed as...
Belantamab Mafodotin Receives Priority Review for Relapsed or Refractory Multiple Myeloma
The United States Food and Drug Administration (FDA) has granted a priority review of a Biologics License Application (BLA) for belantamab mafodotin (GSK2857916), a...
