International non-proprietary name: belantamab mafodotin Procedure No. EMEA/H/C/004935/0000 Note Assessment report as a dopted by the CHMP with all information of a commercially confidential nature deleted. *Data in table 30 corrected in line with SmPC
Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study [published online December 16, 2019].
Belantamab mafodotin-blmf is approved to treat: Multiple myeloma that has relapsed (come back) or is refractory (does not respond to treatment). It is used in adults who have received at least four previous treatments that included an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulating agent. 2020-07-17 8536. Background: Single-agent belantamab mafodotin (B-cell maturation antigen targeting immunoconjugate) showed clinically meaningful activity and manageable safety in patients with heavily pre-treated RRMM (DREAMM-2, NCT03525678, Lancet Oncol.2020).We report updated results (median follow-up 9 months). Methods: DREAMM-2 is an ongoing single-agent belantamab mafodotin (2.5 or … 2021-03-08 Belantamab mafodotin, sold under the brand name Blenrep, is a medication for the treatment of relapsed and refractory multiple myeloma.. The most common adverse reactions include keratopathy (corneal epithelium change on eye exam), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Belantamab mafodotin (BLENREP™; belantamab mafodotin-blmf) is a first-in-class monoclonal antibody-drug conjugate (ADC) that has been developed for the treatment of multiple myeloma by GlaxoSmithKline.
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Qarziba. Dreamm-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination with Four Different Novel Agents in Patients with Relapsed/Refractory Multiple Ja. Nytt 2021 isatuximab (Sarclisa). L01XC39 belantamab mafodotin. Sjukhusvård. Ja. Nytt 2021 belantamab mafodotin (Blenprep). L01XCÖÖ. källa / mål / godkänd / användning / Belantamab mafodotin / Ingenting / mab humaniserat / BCMA / Ingenting / multipelt myelom Namn / handelsbeteckning källa / mål / godkänd / användning / Belantamab mafodotin / Ingenting / mab humaniserat / BCMA / Ingenting / multipelt myelom Namn / handelsbeteckning L01XC39 belantamab mafodotin Godkänd 2020-08-25 GlaxoSmithKline (Ireland) Limited Hum Receptbelagt Nej, ej narkotika Ja The ocular toxicity associated with treatment with belantamab mafodotin is a major safety concern.
Belantamab mafodotin är inte godkänd på någon annan marknad [3]. Troliga framtida försäljningsargument Belantamab mafodotin kommer rimligen föras fram som första läkemedlet i sin klass och en ny behandlingsstrategi för patienter med svårbehandlat multipelt myelom. Författarna till den
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma - Full Text View. Belantamab mafodotin-blmf is approved to treat: Multiple myeloma that has relapsed (come back) or is refractory (does not respond to treatment). It is used in adults who have received at least four previous treatments that included an anti-CD38 monoclonal antibody , a proteasome inhibitor , and an immunomodulating agent .
2021-04-05
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In the pivotal Phase II DREAMM-2 study, single-agent belamaf demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM (Lonial et al. Lancet Oncol 2020).
Belantamab mafodotin-blmf is indicated for treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior thera- pies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Jun 24, 2020 An antibody-drug conjugate, belantamab mafodotin is made up of an antibody targeting the B-cell maturation antigen (BCMA) — a protein found
Sep 2, 2020 Belantamab mafodotin (GSK2857916, belamaf) is a first-in-class antibody-drug conjugate directed at B-cell maturation antigen and has shown
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.
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Mafodotin, a potent microtubule disruptor, prevents multiple myeloma cells from dividing, leading to apoptosis. 1,4 Enhances immune-mediated actions: BLENREP has an afucosylated antibody that enhances recruitment and activation of immune effector cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). 1-3
In the first-in-human, phase 1 DREAMM-1 study, belantamab mafodotin showed promising anti-myeloma activity, inducing responses in heavily pre-treated patients with relapsed or refractory multiple myeloma. Added value of this study Belantamab mafodotin was approved earlier this year in the United States and in the European Union for the treatment of patients with relapsed and/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. 2021-04-05 · Belantamab mafodotin, a B-cell maturation antigen drug-antibody conjugate, is a first-in-class humanised moAb containing a distinct microtubule-disrupting agent: monomethyl auristatin-F.
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Blenrep (belantamab mafodotin-blmf) is a medication used for the treatment of adult patients with relapsed or refractory multiple myeloma whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
The ADC comprises an antibody targeting B-cell maturation antigen (BCMA) conjugated to the microtubule inhibitor monomethyl auristatin F (MMAF). The antibody moiety binds to BCMA on the tumour 2020-06-15 · Belantamab mafodotin produced sustained clinically meaningful responses in patients with relapsed or refractory multiple myeloma, according to findings from the DREAMM-2 study presented at ASCO Belantamab mafodotin är ett nytt cancerläkemedel, avsett som monoterapi vid behandling av recidiverande och refraktärt (behandlingsresistent) multipelt myelom hos vuxna patienter.
Belantamab mafodotin (interim monograph) DRUG NAME: Belantamab mafodotin SYNONYM(S): GSK28579161 COMMON TRADE NAME(S): CLASSIFICATION: miscellaneous. Special pediatric considerations are noted when applicable, otherwise adult provisions apply.
Qarziba. källa / mål / godkänd / användning / Belantamab mafodotin / Ingenting / mab humaniserat / BCMA / Ingenting / multipelt myelom Namn / handelsbeteckning källa / mål / godkänd / användning / Belantamab mafodotin / Ingenting / mab humaniserat / BCMA / Ingenting / multipelt myelom Namn / handelsbeteckning Dreamm-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination with Four Different Novel Agents in Patients with Relapsed/Refractory Multiple Ja. Nytt 2021 isatuximab (Sarclisa). L01XC39 belantamab mafodotin.
Ja. Nytt 2021 belantamab mafodotin (Blenprep). L01XCÖÖ.