Brand Name
Blenrep
Generic Name
Belantamab Mafodotin
View Brand Information FDA approval date: October 23, 2025
Form: Injection
What is Blenrep (Belantamab Mafodotin)?
BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. BLENREP, a B‑cell maturation antigen ‑directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Approved To Treat
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Brand Information
Blenrep (belantamab mafodotin)
WARNING: OCULAR TOXICITY
- BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred
- Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity
- Because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS)
1INDICATIONS AND USAGE
BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
2DOSAGE FORMS AND STRENGTHS
For injection: 70 mg of belantamab mafodotin-blmf as a white to yellow lyophilized powder in a single-dose vial for reconstitution and further dilution.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Ocular Toxicity
- Thrombocytopenia
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Multiple Myeloma in Combination with Bortezomib and Dexamethasone
The safety of BLENREP with bortezomib and dexamethasone (n = 242) compared with daratumumab with bortezomib and dexamethasone (n = 246) was evaluated in DREAMM‑7 in patients with relapsed or refractory multiple myeloma who received at least one prior line of therapy
Serious adverse reactions occurred in 50% of patients who received BVd. Serious adverse reactions in ≥2% of patients included pneumonia (18%), pyrexia (5%), thrombocytopenia (5%), COVID-19 (5%), upper respiratory tract infection (4%), sepsis (4%), second primary malignancy (3%), and anemia (2%). Fatal adverse reactions occurred in 10% of patients who received BVd. Fatal adverse reactions which occurred in >1 patient included pneumonia (4%), sepsis (2%), COVID-19 (1%), respiratory failure (<1%), and intracranial hemorrhage (<1%).
Permanent discontinuation of BLENREP due to an adverse reaction occurred in 17% of patients. Adverse reactions which resulted in permanent discontinuation of BLENREP in ≥3% of patients included ocular toxicity (9%) and pneumonia (4%).
Dosage interruptions of BLENREP due to an adverse reaction occurred in 78% of patients. Adverse reactions which required dosage interruption of BLENREP in ≥3% of patients included ocular toxicity based on ophthalmic exam findings (74%), blurred vision (32%), upper respiratory tract infection (20%), dry eye (14%), photophobia (14%), pneumonia (14%), eye irritation (13%), COVID-19 (12%), foreign body sensation in eyes (12%), eye pain (10%), thrombocytopenia (9%), visual impairment (7%), cataract (5%), diarrhea (4%), and neutropenia (4%).
Dosage reductions of BLENREP due to an adverse reaction occurred in 36% of patients. Adverse reactions which required dosage reductions for BLENREP in ≥3% of patients included ocular toxicity based on ophthalmic exam findings (30%), thrombocytopenia (14%), and blurred vision (10%).
The most common adverse reactions (≥20%) were reduction in BCVA, corneal exam findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, upper respiratory tract infection, hepatotoxicity, eye pain, diarrhea, fatigue, pneumonia, cataract, and COVID-19. The most common Grade 3 or 4 laboratory abnormalities (≥10%) were decreased platelets, decreased lymphocytes, decreased neutrophils, increased gamma glutamyltransferase, decreased white blood cells, and decreased hemoglobin.
Table 4 summarizes the adverse reactions in DREAMM‑7.
Clinically relevant adverse reactions in <10% of patients who received BVd included: increased lacrimation, vomiting, diplopia, albuminuria, sepsis, eye pruritus, infusion-related reactions, corneal ulcer (including cases with infection), and pneumonitis.
Table 5 summarizes the laboratory abnormalities in DREAMM-7.
Patient-reported ocular symptoms were assessed using the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) and Ocular Surface Disease Index (OSDI).
PRO-CTCAE assessments were collected at baseline and then every 3 weeks until treatment discontinuation. Completion rates in both arms were ≥90% at baseline and ≥81% at subsequent timepoints where >50% of patients remained on treatment. OSDI assessments were collected every 3 weeks until the 6
Table 6 summarizes the patient-reported symptom of blurred vision as assessed by PRO-CTCAE.
Driving at night was assessed using the OSDI. At baseline, the proportion of patients who reported limitations with driving at night “all of the time” or “most of the time” during the last week was 9% in the BVd arm and 4% in the DVd arm. The proportion of patients who reported limitations with driving at night “all of the time” or “most of the time” during the last week was highest in the BVd arm at 47% at Week 13 and in the DVd arm at 12% at Week 76.
5DESCRIPTION
Belantamab mafodotin‑blmf is a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate. Belantamab mafodotin‑blmf is an antibody conjugate composed of 3 components: 1) afucosylated, humanized immunoglobulin G1 monoclonal antibody covalently linked to 2) the microtubule inhibitor mcMMAF via 3) a protease‑resistant maleimidocaproyl linker.
The antibody is produced in a mammalian cell line (Chinese Hamster Ovary) using recombinant DNA technology and the microtubule inhibitor and linker are produced by chemical synthesis. Approximately 4 molecules of mafodotin are attached to each antibody molecule. The molecular weight of belantamab mafodotin‑blmf is approximately 152 kDa. Belantamab mafodotin‑blmf has the following structure:
BLENREP (belantamab mafodotin‑blmf) for injection is a sterile, preservative‑free, white to yellow, lyophilized powder in a single‑dose vial for reconstitution and further dilution prior to intravenous use. BLENREP is supplied as 70 mg per vial and requires reconstitution with 1.4 mL of Sterile Water for Injection, USP, to obtain a concentration of 50 mg/mL. Each mL of reconstituted solution contains belantamab mafodotin‑blmf (50 mg) and the inactive ingredients, citric acid monohydrate (0.46 mg), edetate disodium (0.017 mg), polysorbate 80 (0.2 mg), sodium citrate (5.88 mg), and trehalose (68.4 mg). The pH of the reconstituted solution is 6.2.
6CLINICAL STUDIES
Relapsed or Refractory Multiple Myeloma in Combination with Bortezomib and Dexamethasone
The efficacy of BLENREP in combination with bortezomib and dexamethasone (BVd) compared with daratumumab, bortezomib, and dexamethasone (DVd) was evaluated in DREAMM‑7 (NCT04246047), an open‑label, randomized, multicenter study in adult patients with relapsed or refractory multiple myeloma. Patients received at least one prior line of therapy and had documented disease progression during or after their most recent line of treatment. Patients who were refractory or intolerant to daratumumab or bortezomib, or with prior exposure to anti‑BCMA therapy were excluded. Patients with existing corneal disease, except for mild punctate keratopathy, were excluded.
Patients were randomized 1:1 to the following treatment arms:
- BLENREP 2.5 mg/kg (IV) every 3 weeks on Day 1 of each 21‑day cycle. Bortezomib 1.3 mg/m
- Daratumumab 16 mg/kg (IV) every week for Cycles 1–3 and every 3 weeks for Cycles 4–8. Bortezomib 1.3 mg/m
The dose level of dexamethasone in each arm was reduced by half in patients aged 75 years or older. Treatment with BLENREP or daratumumab was continued until disease progression or unacceptable toxicity.
Efficacy was established based on progression-free survival (PFS) and overall survival (OS).
A total of 217 patients who received at least two prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent, were evaluated for efficacy: 108 in the BVd arm and 109 in the DVd arm. Baseline demographics and characteristics were similar across arms. The median age was 65 years (range: 39 to 86); 43% were age 65 to 74 years, 11% age 75 years or older; 53% were male; 86% were White, 11% Asian, 2% Black; R-ISS stage at screening was stage I in 37%, stage II in 56%, stage III in 6%; high‑risk cytogenetics (presence of t (11;14), t (14;16) or 17p13del) were present in 29%; extramedullary disease was present in 11%. The median number of prior lines of therapy was 3 (range: 2 to 7); 2% received a prior anti-CD38 monoclonal antibody, and 71% previously received autologous stem cell transplantation. Overall, 19% of patients were refractory to proteasome inhibitors and 59% were refractory to immunomodulatory agents.
Efficacy results are summarized in
Figure 1: Kaplan-Meier Curve for Progression‑Free Survival in DREAMM-7
Figure 2: Kaplan-Meier Curve for Overall Survival in DREAMM-7
In patients who achieved response, the median time to response was 1.43 months (range: 0.7 to 8.4 months) in the BVd arm and 1.03 months (range: 0.7 to 11.1 months) in the DVd arm.
7REFERENCES
- “OSHA Hazardous Drugs.”
8HOW SUPPLIED/STORAGE AND HANDLING
BLENREP (belantamab mafodotin‑blmf) for injection is a sterile, preservative‑free, white to yellow lyophilized powder for reconstitution and further dilution prior to intravenous use.
BLENREP is supplied in a carton containing one 70 mg single‑dose vial with a rubber stopper (not made with natural rubber latex) and aluminum overseal with removable cap (NDC 0173‑0913‑01).
Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC).
BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA‑approved patient labeling (Medication Guide).
Ocular Toxicity
- Advise patients that ocular toxicity may occur during treatment with BLENREP
- Advise patients to promptly tell their healthcare provider if they notice any new or worsening eye symptoms
- Advise patients that they will be sent to an eye care professional to obtain ophthalmic exams before starting BLENREP, before each dose, promptly for any new or worsening eye symptoms, and as clinically indicated
- Advise patients to administer preservative‑free artificial tears at least 4 times per day starting with the first infusion and continuing until the end of treatment and to avoid wearing contact lenses for the duration of therapy. Bandage contact lenses may be used under the direction of an eye care professional
- Advise patients to use caution when driving or operating machinery as BLENREP may adversely affect their vision
BLENREP REMS
- Advise patients that because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP REMS
- Patients must receive counseling about the risk of ocular toxicity, enroll in the REMS, and adhere to ongoing monitoring via ophthalmic exams. Patients will be given the BLENREP REMS Patient Guide. This guide describes the risk of ocular toxicity with BLENREP
Thrombocytopenia
- Advise patients to inform their healthcare provider if they develop signs or symptoms of bleeding
Embryo‑fetal Toxicity
- Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose
- Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose
Lactation
- Advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose
Infertility
- Advise males and females of reproductive potential that BLENREP may impair fertility
Pneumonitis
- Advise patients to immediately report any new or worsening respiratory symptoms to their healthcare provider
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