TALVEY® (talquetamab-tgvs) | Official HCP Website

Evolve Your Strategy with TALVEY^®

TALVEY^® is the first and only FDA-approved GPRC5D targeting agent^1,2

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For the treatment of adult patients with RRMM who have received ≥4 prior lines of therapy, including a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

National Comprehensive Cancer Network^® (NCCN^®) Recommendation³

CATEGORY 2A

NCCN

PREFERRED

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommend talquetamab-tgvs (TALVEY^®) as an NCCN Category 2A preferred treatment option for multiple myeloma after at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Based upon lower-level evidence, there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.

Powerful efficacy demonstrated with TALVEY^® monotherapy¹

Naïve to T-cell redirection therapy*

73.6% ORR^† with Q2W dosing (95% CI, 63.0%–82.4%) (n=65/87)
73% ORR^† with QW dosing (95% CI, 63.2%–81.4%) (n=73/100)

Exposed to T-cell redirection therapy*

72% ORR^† with QW dosing (95% CI, 53%–86%) (n=23/32)^‡

Versatile treatment option for patients naïve and exposed to T-cell redirection therapy¹

The MonumenTAL-1 trial included patients who were naïve and exposed to T-cell redirection therapy.^*‡

Flexible dosing: either Q2W or QW dosing schedule right from the start¹

Q2W and QW dosing begins after the respective step-up dosing schedule.

MonumenTAL-1 study design: The efficacy of TALVEY^® was evaluated in 219 patients with relapsed or refractory multiple myeloma in the single-arm, open-label, multicenter, phase 1/2 trial. The trial included patients who had received ≥3 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Efficacy was based on ORR and DOR as assessed by an IRC using IMWG criteria.^1,3,4§

^*T-cell redirection therapy refers to both CAR-T and bispecific antibody therapy.

^†ORR: sCR+CR+VGPR+PR.

^‡Of 32 patients, 81% had prior CAR-T and 25% had prior bispecific antibody therapy.

^§Efficacy results reflect patients who received ≥4 prior lines of therapy.

CAR-T, chimeric antigen receptor-T cell; CD, cluster of differentiation; CI, confidence interval; CR, complete response; DOR, duration of response; GPRC5D, G protein-coupled receptor class C group 5 member D; IMWG, International Myeloma Working Group; IRC, Independent Review Committee; ORR, overall response rate; PI, proteasome inhibitor; PR, partial response; QW, once weekly; Q2W, every 2 weeks; RRMM, relapsed or refractory multiple myeloma; sCR, stringent complete response; VGPR, very good partial response.

TALVEY^® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
U.S. FDA approves TALVEY^® (talquetamab-tgvs), a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma. Janssen Biotech, Inc. Updated August 10, 2023. Accessed June 24, 2024. https://www.janssen.com/fda-approves-talveytm-talquetamab-tgvs-first-class-bispecific-therapy-treatment-patients-heavily
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for NCCN Guidelines for Multiple Myeloma V.2.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 11, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.
A study of talquetamab in participants with relapsed or refractory multiple myeloma. ClinicalTrials.gov identifier: NCT04634552. Updated May 23, 2024. Accessed June 11, 2024. https://clinicaltrials.gov/study/NCT04634552

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Evolve Your Strategy with TALVEY®

National Comprehensive Cancer Network® (NCCN®) Recommendation3

Powerful efficacy demonstrated with TALVEY® monotherapy1

Versatile treatment option for patients naïve and exposed to T-cell redirection therapy1

Flexible dosing: either Q2W or QW dosing schedule right from the start1

References