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FDA Approved: Yes (First approved August 5, 2020) Brand name: Blenrep Generic name: belantamab mafodotin-blmf Dosage form: Injection Company: GlaxoSmithKline Treatment for: Multiple Myeloma Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients Early data from the DREAMM-6 study suggest that the combination of belantamab mafodotin, bortezomib, and dexamethasone is active in patients with relapsed or refractory multiple myeloma (MM). 1 These findings were presented by Ajay Nooka, MD, of the Winship Cancer Institute at Emory University in Atlanta, Georgia, as part of the ASCO20 Virtual Scientific Program. Single-agent belantamab mafodotin (B-cell maturation antigen targeting immunoconjugate) showed clinically meaningful ORR was 31% in the 2.5 mg/kg (19% with ≥very good partial responses [VGPR]) and 35% (24% with ≥VGPR) in the 3.4 mg/kg Duration of response (DoR) was not reached (NR) in … Belantamab mafodotin will be administered as an IV infusion at a dose of 2.5 mg/kg every six weeks until progression of disease, unacceptable toxicity or subsequent therapy, for a maximum of eight doses (approximately 12 months), according to the response adapted modifications. Belantamab mafodotin (GSK2857916) is a first-in-class antibody drug conjugate consisting of an anti-BCMA monoclonal antibody bound to the microtubule-disrupting agent, monomethyl auristatin F (MMAF).

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On August 5, 2020, the Food and Drug Administration granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple Belantamab mafodotin is an afucosylated, humanized antibody-drug conjugate directed against B-cell maturation antigen (BCMA); BCMA is expressed on multiple myeloma cells but is mostly absent on naive and memory B cells (Lonial 2020). 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. The ADC comprises an antibody targeting B-cell maturation antigen (BCMA) conjugated to the microtubule inhibitor monomethyl auristatin F (MMAF). Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated patients with relapsed or refractory multiple myeloma. We further investigated the safety and activity of belantamab mafodotin in the DREAMM-2 study. Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma.

Belantamab mafodotin (Blenrep, GSK2857916 or J6M0-MMAF) is an antibody-drug conjugate (ADC) that demonstrates a multifaceted mechanism of action based on three main components.

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1 These findings were presented by Ajay Nooka, MD, of the Winship Cancer Institute at Emory University in Atlanta, Georgia, as part of the ASCO20 Virtual Scientific Program. 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.

Klinisk prövning på Myeloma: Belantamab mafodotin

Jul 15, 2020 The Food and Drug Administration's Oncologic Drugs Advisory Committee voted in favor of the agency approving belantamab mafodotin to  Dec 25, 2020 Belantamab mafodotin is an investigational antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal  Aug 23, 2019 Belantamab mafodotin is a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody, which targets auristatin F, a cytotoxic agent. Belantamab mafodotin is in clinical development for the treatment of multiple myeloma (MM) in patients who are refractory or have relapsed to prior treatments. Sep 16, 2020 Belantamab mafodotin (BLENREP™; belantamab mafodotin-blmf) is a first-in- class monoclonal antibody-drug conjugate (ADC) that has been  Jul 16, 2020 The FDA Oncologic Drugs Advisory Committee voted in favor (12-0) of the approval of belantamab mafodotin (GSK2857916; GlaxoSmithKline)  Jan 1, 2020 About one-third of patients had a response to belantamab mafodotin, and the safety profile was manageable.

belantamab mafodotin.
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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 . 2021-04-09 · Belantamab Mafodotin - Last updated on April 9, 2021 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Educational Resources. 2020-09-16 · 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. The ADC comprises an antibody targeting B-cell maturation antigen (BCMA) conjugated to the microtubule inhibitor monomethyl auristatin F (MMAF).

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. Belantamab mafodotin-blmf caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes. Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Find the safety profile for BLENREP. Learn about corneal adverse reactions and other common adverse events. See Safety Info including BOXED WARNING.
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Inside the cell, free MMAF is released via proteolysis of the monoclonal antibody component. 2020-01-13 belantamab mafodotin Pharmaco-therapeutic group (ATC Code): L01XC39 Therapeutic indication: BLENREP is indicated 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 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]. 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 Belantamab mafodotin is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen (BCMA) conjugated to the microtubule distrupter monomethyl auristatin-F (MMAF). 1 Afucosylation of the Fc region of monoclonal antibodies enhances binding to the Fc region, which enhances antibody dependant cell mediated cytoxicity.

Belantamab mafodotin (Blenrep, GSK2857916 or J6M0-MMAF) is an antibody-drug conjugate (ADC) that demonstrates a multifaceted mechanism of action based on three main components. ADCs are a new class of cancer therapeutics that confer unique pharmacologic activity via mAbs covalently conjugated to a cytotoxic agent via a specialized linker [ 28 ]. 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. Belantamab mafodotin (Blenrep, GlaxoSmithKline, St. Louis, MO, U.S.A) was approved in the European Union as monotherapy for the treatment of adult patients with refractory/relapsed multiple myeloma. Belantamab mafodotin resulted in durable response in highly pretreated patients whose disease is refractory to three classes of agents. Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial. Patients received either belantamab mafodotin-blmf, Learn about BLENREP (belantamab mafodotin-blmf) for appropriate patients with relapsed or refractory multiple myeloma.
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Mike Labruto - Director, Quality Process Improvement - GSK

Single-agent belantamab mafodotin shows anti-myeloma activity with a manageable safety profile in patients with relapsed or refractory multiple myeloma. Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma. Background: Belantamab mafodotin (GSK2857916), an immunoconjugate targeting B-cell maturation antigen, showed single-agent activity in the phase 1 DREAMM-1 study in heavily pre-treated patients with relapsed or refractory multiple myeloma. We further investigated the safety and activity of belantamab mafodotin in the DREAMM-2 study. Learn about BLENREP (belantamab mafodotin-blmf) for appropriate patients with relapsed or refractory multiple myeloma. See Full Safety and Prescribing Info, including BOXED WARNING. BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.