The Scottish Medicines Consortium (SMC) has accepted TALVEY (talquetamab) for use within NHS Scotland as a treatment for adults with relapsed and refractory multiple myeloma who have received at least three previous lines of therapy.

The decision means eligible patients whose disease has progressed following treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody will be able to access the therapy through the NHS in Scotland.

Talquetamab is the first approved bispecific antibody targeting GPRC5D, a receptor found on myeloma cells. The treatment works by binding to both GPRC5D on tumour cells and CD3 on T cells, directing the immune system to attack cancer cells.

The approval addresses a significant unmet need in patients with heavily pre-treated multiple myeloma, where treatment options become increasingly limited as the disease develops resistance to successive therapies.

According to Johnson & Johnson, around 44 patients in Scotland each year could initially benefit from access to talquetamab, with uptake expected to increase as clinical experience grows.

Dr Jennifer Travers, consultant haematologist at the Beatson and Golden Jubilee National Hospital, said: “I am delighted to hear talquetamab has been approved for use in patients with myeloma in Scotland.

“This is excellent news for patients with myeloma to have further options available to treat relapsed myeloma. Access to a bispecific therapy with a different target offers an additional option for patients. More available options for therapy allow clinicians to better tailor therapy for patients, allowing a more personalised approach to treatment for relapsed myeloma.”

The SMC’s decision was based on data from the Phase 1/2 MonumenTAL-1 study, which evaluated talquetamab in patients with relapsed or refractory multiple myeloma.

In the cohort receiving talquetamab 0.8 mg/kg every other week, the overall response rate was 70%. Researchers reported that 59.1% of patients achieved at least a very good partial response, while 40.3% achieved a complete response or better.

After a median follow-up of 23.4 months, the 12-month duration of response rate was 60.6%.

Gabrielle King, senior policy officer at Myeloma UK, said: “This is fantastic news and we know it will make a huge difference to people with myeloma in Scotland.

“Talquetamab targets myeloma in a completely different way to currently available treatments. Myeloma UK has driven every single treatment approval for myeloma since 1997, submitting evidence on behalf of our community and providing expert testimony in committee meetings, because each new pioneering treatment approved on the NHS gives people hope of a brighter future and brings us that much closer to a cure.”

Multiple myeloma is an incurable blood cancer characterised by repeated cycles of remission and relapse. While treatment advances have improved outcomes, most patients eventually require multiple lines of therapy as resistance develops.

The SMC decision provides Scottish clinicians with an additional treatment option that works through a different biological target from existing bispecific antibody therapies available for the disease.