FDA Grants Accelerated Approval to Talquetamab for Patients With R/R Multiple Myeloma

On August 9, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs (talquetamab) for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have previously received 4 or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 

This approval was granted based on findings from the MMY1001 (MonumenTAL-1) single-arm, multicenter study, which enrolled 187 patients with R/R MM who had previously received at least 4 prior systemic therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In the efficacy assessment of this trial, 100 patients received talquetamab at 0.4 mg/kg weekly, following 2 step-up doses during week 1 of therapy, and 87 patients received talquetamab at 0.8 mg/kg every 2 weeks, following 3 step-up doses, until disease progression or unacceptable toxicity occurred. 

Among the 100 patients who received 0.4 mg/kg of talquetamab, the overall response rate was 73% (95% confidence interval [CI], 63.2% to 81.4%) and the median duration of response was 9.5 months (95% CI, 6.5 to not estimable). Among the 87 patients who received 0.8 mg/kg biweekly, the overall response rate was 73.6% (95% CI, 63% to 82.4%) and the median duration of response was unable to be estimated. It was estimated that 85% of patients who responded to this treatment maintained a response for a minimum of 9 months. 

The most common adverse reactions among the 339 patients in the safety population were cytokine release syndrome, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea. Because of these potential adverse reactions, talquetamab is only available through a restricted program under the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS). 

Source: 

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. US Food and Drug Administration; Published online August 10, 2023. Accessed August 10, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma