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About BLENREP (belantamab mafodotin)

For Great Britain (GB) healthcare professionals only - BLENREP is not available in Northern Ireland (NI).

BLENREP has a conditional marketing authorisation.

BLENREP is the first and only licensed B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate for triple-class refractory 5th line plus multiple myeloma1

BLENREP is only available via the private market.

Table of contents

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BLENREP MoA

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What is BCMA?

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BLENREP FAQs

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BLENREP mode of action (MoA)

Watch the BLENREP MoA video below.

Illustration of BLENREP ▼ (belantamab mafodotin) mode of action

Enhances immune mediated actions through recruitment and activation of immune effector cells, and induces antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).1

Illustration of BLENREP ▼ (belantamab mafodotin) mode of action

Delivers the cytotoxic payload that disrupts microtubule networks and induces apoptosis of malignant cells.1

Illustration of BLENREP ▼ (belantamab mafodotin) mode of action

Causes the release of immunogenic cell death markers, which may contribute to an adaptive immune response.1

Think BCMA, think BLENREP

What is BCMA?

BCMA is an ideal target in multiple myeloma. BCMA is:2

  • a cell surface protein expressed predominantly on late-stage B cells and plasma cells
  • required for optimal survival of long-lived plasma cells in the bone marrow
  • expressed on all malignant plasma cells in patients with multiple myeloma

What is BLENREP?

  • BLENREP (belantamab mafodotin) is composed of a humanised anti-BCMA afucosylated monoclonal antibody (belantamab), conjugated to the cytotoxic payload (mafodotin) designed to target myeloma and activate the immune system.1,2

Frequently asked questions

  • BLENREP is a BCMA-targeting antibody-drug conjugate for triple-class refractory multiple myeloma in the 5th line plus setting that works by activating the immune-response against malignant cells and inducing apoptosis.1,2

  • BLENREP is designed to target myeloma and activate the immune system. BLENREP binds to cell surface BCMA of myeloma cells and is rapidly internalised. Once inside the tumour cell, the cytotoxic agent is released, disrupting the microtubule network, leading to cell cycle arrest and apoptosis. The antibody enhances recruitment and activation of immune effector cells, killing tumour cells by ADCC and ADCP. Apoptosis induced by BLENREP is accompanied by markers of immunogenic cell death, which may contribute to an adaptive immune response to tumour cells.1,2

  • 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 least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.1

    This medicinal product has a conditional marketing authorisation.

    A full list of contraindications, special warnings and precautions for using BLENREP can be found in the GB Summary of Product Characteristics here.

  • BLENREP is manufactured by: GlaxoSmithKline Manufacturing SpA, Strada Provinciale Asolana, 90, San Polo di Torrile, Parma 43056, Italy (manufacturer responsible for batch release).

  • The approval of BLENREP is based on data from the ongoing DREAMM-2 study. It included 97 patients with triple-class refractory multiple myeloma who received a 2.5 mg/kg dose every 3 weeks.3

    A broad range of patients were included in the DREAMM-2 study (n=97) – 53% (n=51) were male, with an average age of 65 years and a median of 7 prior multiple myeloma treatments. 42% (n=41) of patients had high-risk cytogenetics* and 43% (n=42) of patients had ISS Stage III disease.3 Find out more about the DREAMM-2 study here.

    *Presence of t(4;14), t(14;16), or 17p13del mutations.3

  • The final analysis data from the DREAMM-2 study demonstrated that treating patients with single-agent BLENREP, administered as a 2.5 mg/kg dose every 3 weeks (n=97), resulted in an overall response rate of 32% (n=31/97) (97.5% CI: 21.7-43.6). 58% of responding patients achieved a very good partial response (VGPR) or better (n=18/31). The median duration of response was 12.5 months (95% CI: 4.2-19.3) and median overall survival was 15.3 months (95% CI: 9.9-18.9) at 40 months follow-up.4 Find out more about the efficacy of BLENREP here.

  • Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, to assess their suitability for treatment with BLENREP.1

  • BLENREP has a generally manageable safety profile. The most common adverse events (≥20%) were keratopathy (corneal epithelium change on eye exam), thrombocytopenia, anemia, blurred vision, nausea, pyrexia, BCVA reduced to 20/50 or worse and infections.4 Find out more about the safety profile for BLENREP here.

  • The recommended dose of BLENREP is 2.5 mg/kg administered as an intravenous infusion once every 3 weeks.1

    It is recommended that treatment with BLENREP should be continued until disease progression or unacceptable toxicity.1

    Find out more about the dosing and administration of BLENREP here.

  • BLENREP should be administered via intravenous infusion, over a minimum of 30 minutes, using an infusion set made of polyvinyl chloride or polyolefin.1

    Find out more about the dosing and administration of BLENREP here.

  • BLENREP is recommended as a treatment option for triple-class refractory patients by the ESMO 2021 multiple myeloma guidelines.5 BLENREP is licensed for patients who are TCR and have received four prior lines of therapy.1

  • Patients receiving BLENREP should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, before the subsequent three treatment cycles, and as clinically indicated while on treatment.1

    Find out more about collaborating with ECPs and management strategies, as outlined in the SmPC, for eye-related side effects associated with BLENREP here.

  • If you have any additional queries regarding BLENREP, you can request a contact from your local account manager here, who will be happy to help you with your enquiry.

Learn more about the efficacy of BLENREP

VIEW EFFICACY DATA

Find out more about what BLENREP can offer your patients

Safety

Discover the safety outcomes for BLENREP

Dosing and administration

Learn how to correctly dose BLENREP

Resources

Dig deeper into BLENREP with our resources library

Prescribing information can be found at the top of this webpage, or here.

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 least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.1

Abbreviations

ADCC, antibody-dependent cellular cytotoxicity; ADCP, antibody-dependent cellular phagocytosis; BCMA, B-cell maturation antigen; DREAMM-2, DRiving Excellence in Approaches to Multiple Myeloma 2; ECP, eye care professional; ESMO, European Society for Medical Oncology; FAQ, frequently asked questions; ISS, international staging system; MoA, mechanism of action;

References

  1. BLENREP Summary of Product Characteristics.
  2. Trudel S et al. Lancet Oncol. 2018;19(12):1641–1653.
  3. Lonial S, et al. Cancer. 2021;127(22):4198–4212.
  4. Ramasamy, K et al. Poster presented at the British Society of Haematology (BSH) on the 63rd Annual Scientific Meeting, 23-25 April 2023, ICC in Birmingham
  5. Dimopoulos MA et al. Ann Oncol. 2021;32(3):309–322.

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or email us on UKSafety@gsk.com.

© 2022 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

February 2024 | PM-GB-BLM-WCNT-220005 (V6.0)