TALVEY^®▼ (talquetamab) receives positive NICE recommendation in Final Draft Guidance for treating relapsed and refractory multiple myeloma after three or more lines of treatment

Talquetamab is a first-in-class bispecific antibody which targets the GPRC5D receptor on myeloma cells, and will now become available to eligible patients throughout England and Wales ^1,2,3

High Wycombe, UK (17 November 2025) – Johnson & Johnson (J&J) today announced that the National Institute for Health and Care Excellence (NICE) has recommended TALVEY®▼ (talquetamab) for use in the NHS across England and Wales in its Final Draft Guidance. This monotherapy has been recommended as an option for treating relapsed and refractory multiple myeloma (RRMM) in adults, after three or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody), when the myeloma has progressed on the last treatment.¹

Multiple myeloma is an incurable blood cancer and nearly all patients will relapse and require subsequent therapy.³ There is a high unmet need for heavily pre-treated patients, as relapses become more common after each line of therapy.^3,4 As a result, not only does multiple myeloma have a significant psychological impact on patients and their caregivers, but after multiple relapses, many patients face the reality of exhausting all available treatments.¹

“We’ve spent months advocating for this treatment to be approved, and we couldn’t be happier to see it rolled out on the NHS in England and Wales,” said Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK.* “Talquetamab offers patients an alternative treatment option that could enable better tailoring to their needs compared to standard treatments. This is a hard-earned victory for patients in England and Wales, but there’s more work to be done. We will keep pushing for talquetamab to be approved in the rest of the UK. Until we have a cure, it is vital that people with myeloma have as many options as possible to keep their disease under control, no matter where they live.”

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).^3,5 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.^3,5 GRPC5D is a receptor protein that is highly expressed in multiple myeloma, making it a strong additional or alternative therapeutic target.^5,6

“Given the relapsing and remitting nature of multiple myeloma, patients can face a challenging care journey,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine. “People with myeloma need access to as many treatments as possible at every stage of their disease, and this is especially important at the later stages when options are more limited. We are delighted to be able to address this treatment need and provide an additional therapy option with a unique target for those eligible on the NHS. Targeted medicines have the potential to help us get in front of cancer by delivering improved outcomes for patients versus standard of care therapies, and we look forward to today’s decision translating into uptake throughout England and Wales.”

The efficacy and safety profile of talquetamab was assessed in the pivotal Phase 1/2 single-arm, open-label, multicentre MonumenTAL-1 clinical trial.^2,3,7 Patients treated with talquetamab 0.4 mg/kg weekly (n=143) experienced an overall response rate (ORR) of 74.1% (n=106) (95% confidence interval [CI], range 66.1-81.1).^2,7 The median duration of follow-up among these patients was 18.8 months and an estimated 51.5% maintained response for at least 9 months.^2,7 In those treated with talquetamab 0.8 mg/kg biweekly (n=145), the ORR was 71.7% (n=104) (95% CI, range 63.7-78.9).^2,7 The median duration of follow-up among these patients was 12.7 months, and an estimated 76.3% maintained response for at least 9 months.^2,7

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

#ENDS#

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.

Adverse events should be reported. ▼ This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via the MHRA. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.

About the MonumenTAL-1 clinical trial^2,3,7,8
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 RRMM 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 a proteasome inhibitor (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. When damaged, these plasma cells rapidly spread and replace normal cells with tumours.9 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.9 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.

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/ .

Follow us at https://www.linkedin.com/company/jnjinnovativemedicineuk.

© Janssen-Cilag Limited, a Johnson & Johnson Company. All rights reserved.

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 , 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.

*Myeloma UK has not been paid for any media work.

November 2025 | CP-552142

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