New ‘Trojan Horse’ multiple myeloma treatment option now approved for eligible Australian patients

• Blenrep® (belantamab mafodotin) has been registered for use in adults with multiple myeloma who have relapsed or become resistant to first-line treatment as part of a triplet combination.^1,2 

• Despite treatment advances, myeloma remains incurable and there is a significant unmet need for new therapies.^3,4,5

• An application for reimbursement via the Pharmaceutical Benefits Scheme will be considered in November.⁶

A new multiple myeloma therapy that works like a “Trojan Horse” to treat cancer from within is now approved for use in Australia. Blenrep® (belantamab mafodotin) is the first drug of its kind to be approved for multiple myeloma and works by targeting and attaching to myeloma cells before killing them from inside.^1,2

This approval means Blenrep can now be used in eligible Australian patients as part of a triplet combination for adults who have received at least one prior therapy for myeloma.¹ It follows international approvals in the UK, US, Europe, Canada and Japan.

Clinicians and patient advocates are today welcoming the approval of this new myeloma therapy option, which has been extensively trialled internationally and around Australia, with 22 sites taking part in pivotal Phase 3 studies.

Commenting on the announcement, Director of Clinical Haematology and Haematology Research at St Vincent’s Hospital, Professor Hang Quach says, despite progress over the last decade, myeloma remains incurable for most people.

“Initial treatment usually involves a combination of three or more therapies. However, most people will find their myeloma eventually returns or stops responding, making follow-up treatment increasingly difficult. That is why having a new ‘Trojan Horse’ treatment like Blenrep, which targets myeloma cells in a completely different way, represents an important advance for patients who need new options in their second line of treatment.”

Myeloma Australia CEO Mark Henderson adds, “The myeloma community is growing, as is the need for new therapies. There are more than 2,600 new cases of myeloma being diagnosed in Australia every year and this number is set to almost double by 2043.

“Unfortunately, fewer than 60 per cent of these patients currently survive five years post diagnosis. This is lower than other more common cancers including breast, prostate and colorectal cancer - underlining the urgent need for new treatment approaches. Blenrep provides a new choice, and we welcome its availability for eligible patients.”

Multiple myeloma is a type of blood cancer that develops in the bone marrow and affects plasma cells - the immune cells that normally produce antibodies to fight infection.  When cancerous, these cells crowd out healthy blood-forming cells and can produce faulty antibodies that make it harder to fight infections.⁷ The most common symptoms of multiple myeloma include bone pain, frequent or prolonged infections, anaemia, kidney problems and abnormal blood counts. ⁸

After each relapse, multiple myeloma can become progressively harder to treat, particularly when the disease stops responding to standard therapies.^5,9 The length of time that subsequent treatments work can get shorter, and quality of life and life expectancy can decline.⁹

Blenrep is an antibody drug conjugate (ADC) that contains a monoclonal antibody (a type of protein) connected to an anti-cancer medicine. The antibody is designed to find and selectively bind to multiple myeloma cells. Once attached, the anti-cancer medicine is delivered directly inside cancer cells to kill them from within. The antibody also helps the body’s own immune system to recognise and clear cancer cells.² 

GSK Australia Vice President and General Manager, Andrew Thomas says, “We welcome the approval of Blenrep and remain committed to making a difference for all Australians with blood cancer. By combining our understanding of the immune system with the latest in scientific innovation, our ambition is to unlock new ways to treat blood cancers like myeloma and change the course of disease.”

Blenrep is indicated for the treatment of adults with multiple myeloma whose disease progresses after initial treatment or no longer responds to initial treatment. It can be used in combination with existing myeloma medicines, bortezomib and dexamethasone in patients who have received at least one prior therapy, or in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.¹ Blenrep is administered as a 30-minute outpatient infusion, meaning it can be delivered without hospitalisation.² 

Like all medicines, Blenrep can cause side effects. Common side effects include fever, general weakness, fatigue, cold or cold-like symptoms, diarrhoea, nausea, constipation, vomiting, foamy or frothy urine (albuminuria), and blood tests showing abnormal levels of creatine phosphokinase, liver problems, anaemia, lymphopenia, leukopenia or neutropenia. Serious side effects include eye-related issues [Please refer to Consumer Medicine Information (CMI) leaflet and Boxed Warning], diarrhoea (significant episodes), disorder of blood vessels in the liver, abnormal bruising or bleeding (thrombocytopenia), lung problems (pneumonitis), pneumonia and infusion-related reactions.² Refer to the CMI leaflet for more information on the observed side effects.

Blenrep is not funded on the Pharmaceutical Benefits Scheme (PBS). Reimbursement of Blenrep in combination with bortezomib and dexamethasone was reviewed by the Pharmaceutical Benefits Advisory Committee at its November 2025 meeting.⁶

The appropriate treatment for an individual is for their healthcare professional to decide, in consultation with the patient.

This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

BLENREP can cause changes to the surface of your eye which can result in changes in vision, blurred vision, and dry eyes. You should have an eye examination by an eye care professional before each dose of BLENREP. Your doctor may request additional eye tests while on treatment with BLENREP. If you have not had vision changes or other eye changes, during the first six doses of BLENREP, your doctor may reduce eye exams to approximately every three months with additional eye exams when needed. Even if your vision seems fine, it is important that you get your eyes checked during treatment with BLENREP because some changes can happen without symptoms and may only be seen on an eye examination. Tell your doctor if you notice changes with your vision. Your doctor may reduce the dose or change the time between doses. Your doctor might also ask you to see an eye care professional.

PBS Information: Blenrep is not listed on the PBS.

About Blenrep (belantamab mafodotin)² 

Safety: Like all medicines, Blenrep can cause side effects. Common side effects include fever, general weakness, fatigue, cold or cold-like symptoms, diarrhoea, nausea, constipation, vomiting, foamy or frothy urine (albuminuria), and blood tests showing abnormal levels of creatine phosphokinase, liver problems, anaemia, lymphopenia, leukopenia or neutropenia. Serious side effects include eye-related issues [Please refer to CMI and Boxed Warning], diarrhoea (significant episodes), disorder of blood vessels in the liver, abnormal bruising or bleeding (thrombocytopenia), lung problems (pneumonitis) pneumonia, and infusion-related reactions.

Eye-related issues: BLENREP can cause changes to the surface of your eye which can result in changes in vision, blurred vision, and dry eyes. You should have an eye examination by an eye care professional before each of the first four doses of BLENREP. [Please refer to CMI and Boxed Warning].

Precautions: Do not stop treatment with this medicine suddenly. Do not use contact lenses while receiving treatment with BLENREP unless instructed by your eye care professional. Do not breastfeed during treatment and for 3 months after your last dose of BLENREP. BLENREP can cause problems with vision that can affect your ability to drive or use machines. Do not drive or use machines unless you are sure your vision is not affected.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 7 Product Details in the Consumer Medicine Information.

Interactions: No formal drug interaction studies have been performed with belantamab mafodotin.

Further information about Blenrep can be found in the Consumer Medicine Information here: https://au.gsk.com/en-au/products/product-list/blenrep/.   

 

About multiple myeloma

About 22,000 people are estimated to be living with multiple myeloma in Australia at any one time.⁷ It is estimated that 2,600 Australians are diagnosed with multiple myeloma each year, and incidence is projected to nearly double by 2043.^10,11

Multiple myeloma develops in the bone marrow and affects plasma cells.⁷ The disease often causes no symptoms until it reaches an advanced stage, and the most common symptoms include bone pain, easy bruising, fatigue and kidney problems.⁸

In Australia, the five-year survival rate for people with multiple myeloma is 60.7%, significantly lower than other more common cancers including breast cancer (92.7%), prostate cancer (96.0%) and colorectal cancer (71.6%).⁴

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

For product information please contact GlaxoSmithKline Australia Pty Ltd. 3/436 Johnston St, Abbotsford VIC 3067. ABN 47 100 162 481. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK or Medical Information on 1800 033 109. Blenrep (belantamab mafodotin) trademarks are owned by or licensed to the GSK group of companies ©2025 GSK group of companies or its licensor. Date of approval: November 2025. NP-AU-BLM-PRSR-250007

Media contacts:

SenateSHJ

Nicki Sambuco - nicki@senateshj.com.au - 0452 446 084

GSK

Angela Hill - angela.m.hill@gsk.com - 0466 514 894

References:

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2. GSK Australia. 2025. Blenrep Consumer Medicine Information, [Online] Available at: https://au.gsk.com/en-au/products/product-list/blenrep/ . Accessed November 2025.
3. Kumar S et al. 2022. Gaps and opportunities in the treatment of relapsed-refractory multiple myeloma: Consensus recommendations of the NCI Multiple Myeloma Steering Committee. Blood Cancer J 12:98.
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9. Myeloma Australia. 2022. Clinical practice guideline: multiple myeloma – Update June 2022. Available at: https://myeloma.org.au/wp-content/uploads/2022/09/MSAG_Myeloma-Clinical-Practice-Guideline-2022_Final.pdf. Accessed November 2025.
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