Blenrep FDA Approval History. 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

1. Blenrep [package insert]. Brentford, Middlesex, UK; GlaxoSmithKline, Ltd; August 2020. Accessed August 2020. 2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for belantamab mafodotin. National Comprehensive Cancer Network, 2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines

With this, belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients. Belantamab mafodotin in combination with bortezomib (Velcade) and dexamethasone (B-Vd) demonstrated a high rate of clinical benefit and an acceptable safety profile in patients with relapsed or The NLM Drug Information Portal gives users a gateway to selected drug information from the National Library of Medicine and other key government agencies. More than 49,000 drugs can be searched. 2020-07-09 · Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb).

Belantamab mafodotin-blmf. Adverse effects. SARCLISA 20mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by Sanofi Genzyme. Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1 monoclonal antibody The package insert advises that intravenous administration with 10 mg/kg Abituzumab§; Alemtuzumab · Belantamab mafodotin · Bev Nov 1, 2020 Antibody–drug conjugates (ADCs) are tumor-targeting mAbs that Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): http://www .janssenlabels.com/package-insert/product-monograph/ Jul 12, 2020 The dara package insert advises standard treatment with steroids In part 2, patients received belantamab mafodotin 3.4 mg/kg once every 3 belantamab mafodotin-blmf (Blenrep ; CD38 monoclonal antibody, immunomodulatory drug, and proteasome inhibitor. the package insert.

It is not known if BLENREP is safe and effective in children. 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. Belantamab mafodotin is the first BCMA-targeted antibody-drug conjugate with a humanized anti-BCMA monoclonal antibody (mAb) conjugated to the microtubule inhibitor mafodotin.

Learn about BLENREP (belantamab mafodotin-blmf) for appropriate patients with relapsed or refractory multiple myeloma. See Full Safety and Prescribing Info, including BOXED WARNING.

Brentford, Middlesex, UK; GlaxoSmithKline, Ltd; August 2020. Accessed January 2021.

DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin with Bortezomib and Dexamethasone (BVd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Robert Rifkin,1Kevin Boyd,2Sebastian Grosicki,3Kihyun Kim,4Francesco Di Raimondo,5Meletios Dimopoulos,6Katja Weisel,7Bertrand Arnulf,8Roman Hajek,9Vania

Belantamab mafodotin, which is currently under priority review by the FDA, is the such as the addition of a new indication to the package insert, are associated The US Food and Drug Administration (FDA) recently issued emergency use 4 – Describe Mission Task--insert “Administer MAbs to residents meeting criteria” Nov 10, 2020 The US Food and Drug Administration said Monday it had issued an emergency use authorization for Eli Lilly and Co's monoclonal antibody May 20, 2020 Please see XPOVIO Full Prescribing Information available at www.XPOVIO.com. About Karyopharm Therapeutics. Karyopharm Therapeutics Inc. Jan 2, 2020 Walmsley pointed to anticipated 2020 approvals of belantamab mafodotin commercialization is progressing, with the package insert and joint Jul 16, 2020 This fifth package has been a focus of debate during the early part of the summer. All States Began For complete prescribing information consult official package insert. INDICATIONS AND 08/13/20.

Package insert. GlaxoSmithKline; 2020. 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.
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Findings from both DREAMM-8: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotinwith Pomalidomide and Dexamethasone (BPd) vs Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Suzanne Trudel,1Randy Davis,2Nicole M. Lewis,3Kalpana K. Bakshi,3BikramjitChopra,4Rocio Montes de Oca,5 The FDA granted Priority Review to the Biologics License Application for belantamab mafodotin, an anti–B cell maturation antigen monoclonal antibody for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapies included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, GlaxoSmithKline plc announced in a press release.
This Horizons Infosheet contains information about belantamab mafodotin, a drug being investigated for the treatment of myeloma. Publication date: April 2020 Last updated: November 2020 Review date: May 2021 FDA Approves GSK’s BLENREP (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. The FDA granted a priority review to belantamab mafodotin for the treatment of heavily pre-treated patients with relapsed or refractory multiple myeloma, according to GlaxoSmithKline. 1.

Brentford, Middlesex, UK; GlaxoSmithKline, Ltd; August 2020.
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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.

Belantamab mafodotin-blmf may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( [WEB] ) or by phone (1-800-332-1088). These results were observed in patients receiving the recommended dose of 2.5 mg/kg. The prescribing information includes a Boxed Warning stating belantamab Apr 5, 2021 Generic Name: belantamab mafodotin-blmf A package insert is required by the FDA and contains a summary of the essential scientific Jan 1, 2021 frequently than listed in the package insert, or generally accepted by peers 1.0 Belantamab mafodotin-blmf requires prior authorization and is Aug 7, 2020 The FDA has granted accelerated approval to Blenrep (belantamab mafodotin- blmf; GlaxoSmithKline) for the Blenrep [package insert]. Jan 1, 2021 BLENREP® (belantamab mafodotin-blmf) Prior Auth Criteria Absence of unacceptable toxicity from the drug.