Blenrep (belantamab mafodotin-blmf)
An approved treatment for Multiple Myeloma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Belantamab mafodotin-blmf wherever you encounter it, plus the key facts at a glance.
- Generic name
- Belantamab mafodotin-blmf
- Brand name
- Blenrep
- Drug class
- BCMA-directed antibody-drug conjugate
- Manufacturer
- GSK (GlaxoSmithKline)
- How it's taken
- IV infusion over about 30 minutes every 3 weeks, with an eye exam before each dose
Blenrep (belantamab mafodotin-blmf) is an antibody-drug conjugate given by IV every 3 weeks for adults with relapsed or refractory multiple myeloma[2].
- The FDA approved the current use on October 23, 2025, with bortezomib and dexamethasone after at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent[3].
- Blenrep's first approval, granted on August 5, 2020 as a single agent after 4 or more prior therapies, was withdrawn at the FDA's request after the DREAMM-3 trial missed its main goal.
- The FDA's list of withdrawn accelerated approvals dates the withdrawal to February 6, 2023, and the FDA announced revocation of the license on March 20, 2023[4][1][5].
- In DREAMM-7, median progression-free survival was 31.3 months with Blenrep against 10.4 months with daratumumab, bortezomib and dexamethasone in the approved group[2].
- Blenrep carries a boxed warning for eye toxicity, so eye exams are required before every dose and it is available only through the Blenrep REMS[2].
- The label states that safety after only 1 prior line has not been established[2].
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Where Belantamab mafodotin-blmf fits
The label limits Blenrep to adults with relapsed or refractory myeloma after at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent[2]. It is given with bortezomib and dexamethasone for 8 cycles, then alone[2]. The label states that safety in people with only 1 prior line has not been established[2]. Blenrep is not approved as a single agent from the start, and the 2020 single-agent use is no longer approved[4].
How Belantamab mafodotin-blmf works
Blenrep is an antibody-drug conjugate, an antibody that carries a cell-killing drug straight to its target[2]. Its antibody binds B-cell maturation antigen (BCMA), a protein on myeloma cells and normal B cells[2].
Once Blenrep binds, the myeloma cell pulls it inside, and the attached drug (a form of MMAF) is cut free[2]. MMAF breaks down microtubules, the scaffolding a cell needs to divide, so the cell stops dividing and dies[2]. The antibody also flags myeloma cells for attack by immune cells[2]. Each antibody carries about 4 drug molecules[2].
Side effects and safety
- Eye toxicity. Occurred in 92% in DREAMM-7, grade 3 or 4 in 77%; 83% needed a dose change, and 67% had a dose pause longer than 3 weeks.
- Blenrep REMS. Prescribers, infusion sites and patients must enroll; patients get a REMS Patient Guide and must keep eye monitoring.
- Low platelets. Occurred in 100% of DREAMM-7 patients, grade 3 in 29% and grade 4 in 45%; blood counts are checked at baseline and during treatment.
- Harm to an unborn baby. Blenrep carries a genotoxic drug; effective birth control is advised for 4 months after the last dose for women and 6 months for men with female partners.
- Eye exam with slit lamp and vision test by an ophthalmologist or optometrist at baseline, before every dose and for any new eye symptoms
- Preservative-free artificial tears at least 4 times a day from the first infusion to the end of treatment
- No contact lenses during treatment unless an eye care professional directs bandage lenses
- Complete blood counts at baseline and during treatment
Blenrep has a boxed warning, the FDA's strongest label warning, for eye toxicity[2]. Blenrep changes the corneal epithelium, the clear outer surface of the eye, which can blur vision and cause severe vision loss and corneal ulcers[2].
In DREAMM-7, eye problems affected 92% of people on Blenrep, and 77% had grade 3 or 4 eye toxicity[2]. The most common eye effects were[2]:
- Reduced best-corrected vision: 89%
- Corneal changes found on eye exam: 86%
- Blurred vision: 66%
- Dry eye: 51%
- Light sensitivity: 47%
- Feeling something in the eye: 44%
The first moderate or worse eye finding appeared a median of 43 days after starting, and these episodes lasted a median of 85 days[2]. People had a median of 3 episodes[2]. Dose changes for eye problems were needed in 83%[2].
Low platelets occurred in every patient in DREAMM-7, with grade 3 in 29% and grade 4 in 45%[2]. Bleeding of grade 2 or higher occurred in 7% of patients while their platelets were very low (grade 3 or 4)[2]. Serious side effects affected 50%, most often pneumonia (18%)[2]. Blenrep can harm an unborn baby, and the label advises birth control for 4 months after the last dose for women and 6 months for men with female partners[2].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Belantamab mafodotin-blmf
Blenrep is given as an IV infusion over about 30 minutes at an infusion center[2]. The dose is 2.5mg/kg of actual body weight once every 3 weeks[2]:
Dose changes are common and built into the label[2]. Reduced doses are 1.9mg/kg every 3 weeks, then 1.9mg/kg every 8 weeks for repeated eye problems[2]. By cycle 3 in DREAMM-7, 53% had a dose pause or reduction and only 40% received the planned dose[2].
An eye care professional examines the eyes before every dose[2]. Patients use preservative-free artificial tears at least 4 times a day and avoid contact lenses[2].
Blenrep is available only through the Blenrep REMS, a restricted safety program[2]. Prescribers and infusion sites must be certified, and patients must enroll and keep up with eye monitoring[2]. REMS information is at www.BLENREPREMS.com and 1-855-690-9572[2].
Availability and cost
Only available as the brand-name product.
Help paying for Blenrep
With private insurance, the drugmaker's copay card can lower what you pay for Blenrep. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 5 charity funds for Multiple Myeloma, 1 was open on October 26, 2026. People on Medicare may still qualify for the drugmaker's free medicine program. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
Eligible commercially insured patients may pay as little as $0 per dose of Blenrep, subject to an annual program maximum. Not for anyone eligible for or enrolled in Medicare, Medicaid, Medigap, VA, DoD, TRICARE or other government prescription coverage. Eligibility is reassessed every year.
For: private insurance · source - Infusion cost help
Within the copay program, administration costs are covered up to $100 per administration (not for Massachusetts or Rhode Island residents). Out-of-pocket costs for eye exams the label requires are covered up to $3,000 a year (not for Minnesota, Michigan or Rhode Island residents). Both count toward the annual copay maximum.
For: private insurance · source - Free medicine program
The GSK Patient Assistance Program for Blenrep, run by the independent GSK Patient Access Programs Foundation, may help people who are uninsured or have Medicare and meet income and other program rules.
For: no insurance, Medicare · source - Insurance and case manager help
A Nurse Navigator helps with insurance coverage questions, finding an infusion site or eye doctor, and financial assistance options. Call 1-844-4GSK-ONC (844-447-5662), Monday to Friday, 8 AM to 8 PM ET.
The official page does not say who qualifies. Ask the program. · source
Good to know: The annual copay maximum may be lowered if a plan uses a copay maximizer program. Doctor's office visits, labs and other services are not covered by the copay program. GSK also links to a search tool for independent foundations, which set their own eligibility.
Charity funds for Multiple Myeloma
- From a charity · HealthWell FoundationMultiple Myeloma (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
DREAMM-7 (NCT04246047) was an open-label, randomized trial comparing Blenrep, bortezomib and dexamethasone (BVd) with daratumumab, bortezomib and dexamethasone (DVd)[2][6]. The approval rests on the 217 patients who had at least 2 prior lines including a proteasome inhibitor and an immunomodulatory agent[3]. Of those, 108 got BVd and 109 got DVd[3]. The trial left out people refractory or intolerant to daratumumab or bortezomib, and people with prior BCMA therapy[2].
Results in that group, from the label[2]:
Only 2% of this group had received an anti-CD38 antibody before[2].
DREAMM-3, the confirmatory trial for the original 2020 approval, compared single-agent Blenrep with pomalidomide and dexamethasone in 325 people[5]. GSK said in November 2022 that DREAMM-3 did not meet the requirements of the FDA's accelerated approval rules[5].
Development history
Blenrep has had 2 separate FDA approvals[4][3]:
- August 5, 2020: accelerated approval as a single agent for adults after at least 4 prior therapies, including an anti-CD38 antibody, a proteasome inhibitor and an immunomodulatory agent[4].
- November 22, 2022: GSK announced it had started withdrawing the US marketing authorization at the FDA's request, based on DREAMM-3[5].
- February 6, 2023: the FDA lists this as the withdrawal date for the 2020 indication[4].
- October 23, 2025: the FDA approved Blenrep with bortezomib and dexamethasone after at least 2 prior lines, based on DREAMM-7[3].
Accelerated approval lets the FDA approve a drug on early evidence, such as response rates, on the condition that later trials confirm a benefit[5]. During the withdrawal, GSK offered patients already enrolled in the Blenrep REMS a compassionate use program to continue treatment[5]. GSK said at the time that it still believed the benefit-risk profile was favorable[5].
The 2025 approval is a new use, not a return of the 2020 single-agent indication[2][3]. Blenrep received orphan drug designation[3].
Explore Multiple Myeloma trials
Other Multiple Myeloma treatments
Blenrep is an antibody-drug conjugate aimed at BCMA, the same target used by several newer myeloma treatments. Other BCMA medicines work differently: the CAR T therapies Abecma and Carvykti are one-time infusions of engineered T cells, and bispecific antibodies redirect the body's T cells. DREAMM-7 is a head-to-head trial, and in its approved group Blenrep with bortezomib and dexamethasone gave longer progression-free and overall survival than daratumumab with the same 2 drugs[2].
That comparison does not apply to people already refractory to daratumumab, who were excluded[2].
Common questions about Belantamab mafodotin-blmf
▸What is Belantamab mafodotin-blmf (Blenrep)?
Blenrep (belantamab mafodotin-blmf) is an antibody-drug conjugate given by IV every 3 weeks for adults with relapsed or refractory multiple myeloma[2]. The FDA approved the current use on October 23, 2025, with bortezomib and dexamethasone after at least 2 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent[3]. Blenrep's first approval, granted on August 5, 2020 as a single agent after 4 or more prior therapies, was withdrawn at the FDA's request after the DREAMM-3 trial missed its main goal. The FDA's list of withdrawn accelerated approvals dates the withdrawal to February 6, 2023, and the FDA announced revocation of the license on March 20, 2023[4][1][5]. In DREAMM-7, median progression-free survival was 31.3 months with Blenrep against 10.4 months with daratumumab, bortezomib and dexamethasone in the approved group[2]. Blenrep carries a boxed warning for eye toxicity, so eye exams are required before every dose and it is available only through the Blenrep REMS[2]. The label states that safety after only 1 prior line has not been established[2].
▸How does Belantamab mafodotin-blmf work?
Blenrep is an antibody-drug conjugate, an antibody that carries a cell-killing drug straight to its target[2]. Its antibody binds B-cell maturation antigen (BCMA), a protein on myeloma cells and normal B cells[2].
Once Blenrep binds, the myeloma cell pulls it inside, and the attached drug (a form of MMAF) is cut free[2]. MMAF breaks down microtubules, the scaffolding a cell needs to divide, so the cell stops dividing and dies[2]. The antibody also flags myeloma cells for attack by immune cells[2]. Each antibody carries about 4 drug molecules[2].
▸What are the side effects of Belantamab mafodotin-blmf?
Blenrep has a boxed warning, the FDA's strongest label warning, for eye toxicity[2]. Blenrep changes the corneal epithelium, the clear outer surface of the eye, which can blur vision and cause severe vision loss and corneal ulcers[2].
In DREAMM-7, eye problems affected 92% of people on Blenrep, and 77% had grade 3 or 4 eye toxicity[2]. The most common eye effects were[2]: Reduced best-corrected vision: 89% Corneal changes found on eye exam: 86% Blurred vision: 66% Dry eye: 51% Light sensitivity: 47% Feeling something in the eye: 44%
The first moderate or worse eye finding appeared a median of 43 days after starting, and these episodes lasted a median of 85 days[2]. People had a median of 3 episodes[2]. Dose changes for eye problems were needed in 83%[2].
Low platelets occurred in every patient in DREAMM-7, with grade 3 in 29% and grade 4 in 45%[2]. Bleeding of grade 2 or higher occurred in 7% of patients while their platelets were very low (grade 3 or 4)[2]. Serious side effects affected 50%, most often pneumonia (18%)[2]. Blenrep can harm an unborn baby, and the label advises birth control for 4 months after the last dose for women and 6 months for men with female partners[2].
▸How is Belantamab mafodotin-blmf taken?
Blenrep is given as an IV infusion over about 30 minutes at an infusion center[2]. The dose is 2.5mg/kg of actual body weight once every 3 weeks[2]:
- Cycles 1 to 8: Blenrep together with bortezomib and dexamethasone[2].
- Cycle 9 onward: Blenrep alone, until the myeloma progresses or side effects become unacceptable[2].
Dose changes are common and built into the label[2]. Reduced doses are 1.9mg/kg every 3 weeks, then 1.9mg/kg every 8 weeks for repeated eye problems[2]. By cycle 3 in DREAMM-7, 53% had a dose pause or reduction and only 40% received the planned dose[2].
An eye care professional examines the eyes before every dose[2]. Patients use preservative-free artificial tears at least 4 times a day and avoid contact lenses[2].
Blenrep is available only through the Blenrep REMS, a restricted safety program[2]. Prescribers and infusion sites must be certified, and patients must enroll and keep up with eye monitoring[2]. REMS information is at www.BLENREPREMS.com and 1-855-690-9572[2].
▸Is Belantamab mafodotin-blmf FDA approved?
Yes, Belantamab mafodotin-blmf (Blenrep) is FDA approved (2020) for the treatment of Multiple Myeloma.
▸Why was Blenrep taken off the market?
Blenrep's original 2020 approval was withdrawn after its confirmatory trial, DREAMM-3, did not meet the FDA's accelerated approval requirements, according to GSK[5].
Announcement: GSK announced on November 22, 2022 that it had started the withdrawal at the FDA's request[5].
Official date: The FDA lists February 6, 2023 as the withdrawal date[4].
What it covered: The withdrawn use was Blenrep alone after at least 4 prior therapies[4].
Source: GSK press release, November 22, 2022; FDA withdrawn cancer accelerated approvals list
▸Is Blenrep FDA approved again?
Yes, the FDA approved Blenrep on October 23, 2025, with bortezomib and dexamethasone[3].
Who: Adults with relapsed or refractory myeloma after at least 2 prior lines, including a proteasome inhibitor and an immunomodulatory agent[3].
Basis: The DREAMM-7 trial against daratumumab, bortezomib and dexamethasone[3].
REMS: Blenrep is available only through the Blenrep REMS because of eye risks[3].
Source: FDA approval announcement, October 23, 2025
▸How often do I need eye exams on Blenrep?
The Blenrep label calls for an eye exam at baseline, before every dose and promptly for any new or worse eye symptoms[2].
Who does it: An eye care professional, such as an ophthalmologist or optometrist, does a slit lamp exam and a vision test[2].
Eye drops: Preservative-free artificial tears at least 4 times a day, from the first infusion to the end of treatment[2].
Contacts: The label advises avoiding contact lenses during treatment[2].
Source: Blenrep prescribing information (DailyMed)
▸Does Blenrep cause permanent vision loss?
The Blenrep label reports severe vision changes and corneal ulcers, and not every eye episode cleared in the trial[2].
How often: Eye toxicity occurred in 92% of DREAMM-7 patients on Blenrep, grade 3 or 4 in 77%[2].
Recovery: Of people with moderate or worse eye findings, 42% had their last episode improve to grade 1 or better, and 22% returned to baseline[2].
Duration: These episodes lasted a median of 85 days[2].
Source: Blenrep prescribing information (DailyMed)
▸Is there help paying for Blenrep?
GSK's Together with BLENREP program offers a copay program for eligible commercially insured patients, and the price is not stated on the label[7].
Eye exams: The copay program also helps with out-of-pocket costs for required eye exams, up to an annual maximum of $3,000[7].
Free drug: The GSK Patient Assistance Program may help uninsured patients or those with Medicare who meet income rules[7].
Phone: A Nurse Navigator can be reached at 1-844-447-5662[7].
Source: Together with BLENREP cost support page (GSK)
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration · 2023-03-20. FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma, with update on the withdrawal of the biologics license. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma
- U.S. National Library of Medicine, DailyMed (GlaxoSmithKline LLC) · 2025-10. BLENREP (belantamab mafodotin-blmf) for injection, full prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aef7c34c-fef8-407c-99c0-a68aded53c60
- U.S. Food and Drug Administration · 2025-10-23. FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma
- U.S. Food and Drug Administration · 2026-10-05. Withdrawn | Cancer Accelerated Approvals. https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
- GSK · 2022-11-22. GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization. https://us.gsk.com/en-us/media/press-releases/gsk-provides-an-update-on-blenrep-belantamab-mafodotin-blmf-us-marketing-authorization/
- ClinicalTrials.gov · 2026-11. Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 7). https://clinicaltrials.gov/study/NCT04246047
- GSK · 2026-11. Together with BLENREP Cost Support. https://www.togetherwithgsk.com/blenrep/patient/cost-support/