FDA Approves Talquetamab-Tgvs For Adults with Relapsed Or Refractory Multiple Myeloma Patients with at least Four Prior Lines of Therapy

1 min read

By Dr. Anish Shah

Bronx Lebanon Hospital


On August 9, 2023, the U.S. Food and Drug Administration approved talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with multiple myeloma with relapsed or refractory disease that has not responded to at least four prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.


Study ID number: NCT03399799


Approval was based on the MonumenTAL-1 study, a single-arm, open-label, multicenter study that included 187 patients with relapsed or refractory multiple myeloma meeting the specified inclusion criteria. Talquetamab-tgvs was administered subcutaneously either as 0.4 mg/kg weekly, following two step-up doses in the first week, or as 0.8 mg/kg biweekly, following three step-up doses, until disease progression or unacceptable toxicity.


Efficacy was established by measuring overall response rate (ORR) and duration of response (DOR). The ORR in 100 patients receiving 0.4 mg/kg weekly was 73% (95% CI: 63.2%, 81.4%) with a median DOR of 9.5 months (95% CI: 6.5, not estimable). Likewise, ORR in 87 patients receiving 0.8 mg/kg biweekly was 73.6% (95% CI: 63%, 82.4%) with a median DOR that was not estimable. About 85% of responders maintained a response for at least nine months.


The prescribing information included a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Other common adverse reactions (≥ 20%) include dysgeusia, nail disorder, skin disorder, rash, myalgia, fatigue, weight loss, xerostomia, xerosis, dysphagia, pyrexia, upper respiratory tract infection, and diarrhea, among others.


The FDA approved talquetamab-tgvs for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The recommended doses are either 0.4 mg/kg weekly or 0.8 mg/kg biweekly subcutaneously. The drug comes with a Boxed Warning due to the risks of CRS and neurologic toxicity.

Latest from Blog

ASCO24 LAURA Trial Summary

By: Zhiting Tang1, Lei Deng2 1. Unity Hospital, Rochester Regional Health, Rochester, NY2. University of Washington/Fred