Articles tagged with: Blenrep
Press Releases»
- BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved in the European Union
- Marketing authorisation follows the recent US approval of BLENREP
London, United Kingdom (Press Release) – GlaxoSmithKline plc today announced the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose …
Press Releases»
- BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody
- BLENREP is the fifth major medicine approval for GSK in 2020
London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in …
Press Releases»

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Dr Axel Hoos, Senior Vice President and Head …
Press Releases»
- Recommendation based on review of DREAMM clinical trial programme, including the pivotal DREAMM-2 study
- If approved, belantamab mafodotin will be a first-in-class anti-BCMA therapy for the treatment of relapsed / refractory multiple myeloma
London, United Kingdom (Press Release) – GlaxoSmithKline today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Two committee members could not participate in the final vote.
Dr Axel Hoos, Senior Vice President and Head of …
Press Releases»

Stamford, CT (Press Release) – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the first patient has been dosed in a Phase 1b clinical trial evaluating SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat, in combination with GlaxoSmithKline’s (GSK) investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, belantamab mafodotin, in patients with relapsed or refractory multiple myeloma. The nirogacestat and belantamab mafodotin combination is being evaluated as a sub-study in GSK’s ongoing DREAMM-5 platform trial.
Gamma secretase inhibition …
Press Releases»

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s Biologics License Application (BLA) for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The ODAC will meet virtually on 14 July 2020.
Dr Axel Hoos, Senior Vice President and Head of Oncology …
Press Releases»
- Belantamab mafodotin accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP)
- Submission based on data from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) recently published in The Lancet Oncology
London, United Kingom (Press Release) – GlaxoSmithKline plc today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab mafodotin was accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP).
Accelerated assessment is granted if the CHMP determines the treatment is of major interest from a public health perspective …