FDA Approves Teclistamab for Patients With Relapsed/Refractory MM

On October 25, 2022, the US Food and Drug Administration (FDA) granted expedited approval to teclistamab-cqyv for adult patients with relapsed or refractory multiple myeloma (MM) who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The approval was based on efficacy demonstrated by the MajesTEC-1 trial, an open-label, single-arm, multi-cohort, open-label, multi-center trial of teclistamab-cqyv that included 110 patients who had received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not received prior BCMA-targeted therapy.

The main efficacy outcome measure was overall response rate (ORR) through week 25. ORR included was determined by the Independent Review Committee (IRC) assessment using International Myeloma Working Group 2016 criteria. ORR was 61.8% (95% confidence interval [CI], 52.1 to 70.9). With a median follow-up of 7.4 months among responders, the estimated duration of response (DOR) rate was 90.6% (95% CI, 80.3% to 95.7%) at 6 months and 66.5% (95% CI, 38.8% to 83.9%) at 9 months.

Notably, the prescribing information for teclistamab-cqyv includes a Boxed Warning for life-threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among patients who received teclistamab-cqyv at the recommended dose, CRS occurred in 72% of patients, neurologic toxicity in 57%, and ICANS in 6%. Grade 3 CRS occurred in 0.6% of patients and Grade 3 or 4 neurologic toxicity occurred in 2.4%. Because of the risks of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli REMS.

The study found that the most common adverse reactions (≥20%) occurring in the 165 patients in the safety population, were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Source:

FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. Press Release. The US Food and Drug Administration. Published online October 25, 2022. Accessed October 26, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma