On November 22, 2022, GSK announced it has initiated the process for withdrawal of the U.S. marketing authorization for Blenrep (belantamab mafadotin-blmf) following the request of the U.S. Food and Drug administration (FDA). This request was based upon the previously announced outcome of the DREAMM-3 phase III confirmatory trial which did not meet the requirements of the FDA Accelerated Approval regulations. Read this IMF news alert here, and a full update from GSK here.
In November 2023, GSK made another announcement about Blenrep in a Phase III trial.
What Is Blenrep?
Blenrep® (belantamab mafodotin-blmf) is an antibody-drug conjugate (ADC), the first in a new class of treatments for myeloma. Blenrep is the combination of a monoclonal antibody (mAb) that binds to a specific receptor on the surface of myeloma cells called B-cell maturation antigen (BCMA). It is coupled with monomethyl auristatin F (MMAF), a drug that can kill myeloma cells.
BCMA is involved in myeloma cell growth and survival and is found on the surface of cells in all patients with myeloma. When the monoclonal antibody portion of Blenrep attaches to BCMA, Blenrep enters the cell and releases MMAF, which leads to cell death. The antibody part of the ADC attracts your body’s own immune system to recognize myeloma cells and attack them.
Who Is a Candidate for Blenrep?
The Food and Drug Administration (FDA) had approved Blenrep for adult patients with relapsed or refractory myeloma who had received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. See the full update as this drug has been withdrawn from the U.S. market.
What Are the Dose and Schedule of Blenrep?
Blenrep is given at a starting dose of 2.5 mg/kg, but the dose may be reduced in subsequent infusions. Blenrep is administered as an intravenous infusion once every 3 weeks, over approximately 30 minutes each time, until disease progression or unacceptable toxicity.
What Are the Possible Side Effects of Blenrep?
Blenrep can cause changes to the surface of your eyes that can lead to
- dry eyes
- blurred vision
- worsening vision
- severe vision loss
- corneal ulcer
Your doctor will conduct eye examinations prior to your first dose of Blenrep, prior to each subsequent dose, and promptly for worsening symptoms. The healthcare facility and the doctor must be certified, and the patient must be enrolled in the Blenrep REMS (Risk Evaluation and Mitigation Strategy) program at blenrepREMS.com or 1-855-209-9188. The Blenrep REMS program mandates a visit with an eye specialist prior to your first dose of Blenrep and prior to each subsequent dose.
Low levels of platelets (thrombocytes) can lead to bleeding. Your doctor will monitor your platelet counts before you begin treatment with Blenrep and during treatment as needed. Your doctor may interrupt or reduce your dose of Blenrep, or may stop treatment altogether.
Your doctor may choose to treat thrombocytopenia with medication or with platelet infusion.
Your doctor may give you medication prior to your infusions, or may slow down or stop your treatment with Blenrep, depending on the severity of infusion-related reactions.
Pregnancy, Lactation, and Reproductive Potential
Females of reproductive potential and males with female partners of reproductive potential must consult their doctor prior to initiating treatment with Blenrep. Blenrep may impair fertility, cause fetal harm when administered to pregnant women, and result in serious adverse reactions in the breastfed child.
For Blenrep access and reimbursement services, call GSK Response Center: 1-877-768-0092 (8 a.m. - 8 p.m. EST, Monday-Friday). For information about Blenrep REMS, visit blenreprems.com, or call 1-855-209-9188.
The International Myeloma Foundation medical and editorial content team
Comprised of leading medical researchers, hematologists, oncologists, oncology-certified nurses, medical editors, and medical journalists, our team has extensive knowledge of the multiple myeloma treatment and care landscape. Additionally, Dr. Brian G.M. Durie reviews and approves all medical content on this website.
Last Medical Content Review: August 9, 2021