TALVEY®▼ (talquetamab) is accepted for use within NHS Scotland for treating relapsed and refractory multiple myeloma after three or more lines of treatment

Talquetamab is the first bispecific antibody that targets the GPRC5D receptor on myeloma cells, a mechanism of action distinct from other bispecific antibodies licensed for the same indication^1,2,3

In the pivotal Phase 1/2 MonumenTAL-1 study cohort treated with talquetamab 0.8 mg/kg every other week (n=154), around 7 in 10 patients saw their cancer respond to treatment (70%), with deep and durable responses seen after a median follow up of 23.4 months;^4,1 these results were considered clinically meaningful by the SMC in the context of a heavily pre-treated population characterised by treatment resistance.¹

High Wycombe, UK (08 June 2026) – Johnson & Johnson welcomes the decision made today by the Scottish Medicines Consortium (SMC) to accept TALVEY®▼ (talquetamab) for use within the NHS in Scotland. The treatment has been accepted as a monotherapy for adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.¹

Multiple myeloma is an incurable blood cancer and the vast majority of patients will relapse and require subsequent treatment.³ There is a high unmet need for heavily pre-treated patients, as relapses become more common after each line of therapy.^3,5 As a result, multiple myeloma can have a significant psychological impact on patients and their caregivers, including fear of relapse and anxiety about their futures – alongside social impacts whereby this uncertainty can stop people living their lives as they would like to.⁶ The availability of talquetamab in Scotland could help around 44 Scottish patients each year who are in need of an additional treatment option, with uptake expected to increase over time as clinical experience grows.¹

“I am delighted to hear talquetamab has been approved for use in patients with myeloma in Scotland,” said Dr Jennifer Travers, Consultant Haematologist, Beatson, West of Scotland Cancer Centre, Golden Jubilee National Hospital. “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.”

“This is fantastic news and we know it will make a huge difference to people with myeloma in Scotland,” said Gabrielle King, Senior Policy Officer at blood cancer charity Myeloma UK. “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.”

Talquetamab is a bispecific antibody that binds G protein-coupled receptor family C group 5 member D (GPRC5D) on myeloma cells and cluster of differentiation 3 (CD3) on T-cells (a type of white blood cell that helps the immune system fight disease).^3,7 By redirecting the T-cells to the GPRC5D-expressing myeloma cells, talquetamab activates the T-cells to attack the myeloma cells, resulting in tumour cell death.^3,7 GPRC5D is a receptor protein that is highly expressed in multiple myeloma, making it a strong additional or alternative therapeutic target.^7,8

“For people living with multiple myeloma, treatment options can become increasingly limited as the disease progresses, particularly for those who have already received several lines of therapy,” said Nina Pinwill, UK Director of Strategic Access, Pricing and Operations, Johnson & Johnson. “The SMC’s acceptance of talquetamab is an important step for eligible patients across Scotland, supporting NHS access to an additional option in a later line setting where the unmet need remains high. We are pleased to have brought this innovation with a distinct target to the multiple myeloma community and hope it translates into improved lives.”

The SMC’s acceptance is based on the efficacy and safety profile of talquetamab which was assessed in the pivotal Phase 1/2 single-arm, open-label, multicentre MonumenTAL-1 study.³ In the cohort treated with talquetamab 0.8 mg/kg every other week (n=154), the overall response rate (ORR) was 70% (107/154). Responses were robust and durable with 59.1% of patients achieving at least a very good partial response and 40.3% achieving a complete response or better. After a median follow-up of 23.4 months, the 12-month duration of response rate was 60.6% (95% CI: 50.4-69.4).^4,1

As described in the Summary of Product Characteristics, in patients treated with talquetamab (n=339), the most frequent adverse events of any grade were cytokine release syndrome (77%), dysgeusia (72%), hypogammaglobulinemia (67%), nail disorder (56%), musculoskeletal pain (48%), anaemia (47%), fatigue (43%), weight decreased (40%), rash (39%), skin disorder (37%), dry mouth (36%), neutropenia (35%), pyrexia (33%), xerosis (32%), thrombocytopenia (30%), upper respiratory tract infection (29%), lymphopenia (27%), diarrhoea (25%), dysphagia (24%), pruritus (23%), cough (23%), pain (22%), decreased appetite (22%) and headache (20%).² The most frequent adverse reactions leading to treatment discontinuation were immune effector cell-associated neurotoxicity syndrome (ICANS) (1.1%) and weight decreased (0.9%).²

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About talquetamab
Talquetamab is a bispecific antibody that binds to the CD3 receptor on the surface of T-cells and GPRC5D, a multiple myeloma target, which is highly expressed on the surface of myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as cells of the skin and tongue.^2,3

Talquetamab is licensed for use in the United Kingdom as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.²

Important safety information
For a full list of side effects and information on dosage and administration, contraindications, special warnings and precautions when using talquetamab, please refer to the Summary of Product Characteristics for further information.

About the MonumenTAL-1 clinical trial^3,4,9,10
MonumenTAL-1 (NCT03399799/NCT04634552) is an ongoing Phase 1/2, single-arm, open-label, multicentre study evaluating the efficacy and safety of talquetamab. All patients included in the study had relapsed and refractory multiple myeloma and were intolerant to, or progressed on, established therapies (Phase 1) or showed disease progression after three or more prior lines of therapy, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody (Phase 2). Participants received talquetamab in either 0.4 mg/kg weekly and 0.8 mg/kg every other week with subcutaneous dosing. The primary endpoint of the study was ORR, with secondary endpoints being duration of response, progression-free survival, overall survival, safety, immunogenicity and pharmacokinetics.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.¹¹ When damaged, these plasma cells rapidly spread and replace normal cells with tumours.¹¹ In the UK, there are around 6,200 new multiple myeloma cases diagnosed every year, and over 33,000 people are living with the disease.¹¹ In Scotland, there were 505 new cases of multiple myeloma and malignant plasma cell neoplasms (other cancers that also arise form plasma cells) diagnosed in 2023.¹² While some patients with multiple myeloma initially show no signs of the disease, most patients are diagnosed due to symptoms that can include bone disease or pain, frequent infections, tiredness, peripheral neuropathy, high calcium levels or kidney problems.¹³

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/innovativemedicine/uk/.

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Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.https://scottishmedicines.org.uk/medicines-advice/talquetamab-talvey-full-smc2863/