FDA Approves Biweekly Dosing of Teclistamab for Patients With Relapsed/Refractory Multiple Myeloma

On February 20, 2024, the United States Food and Drug Administration (FDA) approved bispecific antibody targeting B-cell maturation antigen (BCMA)-directed CD3 T-cell engager teclistamab administered at biweekly dosing for patients with relapsed/refractory (R/R) multiple myeloma (MM), according to a press release by Johnson & Johnson through PR Newswire. 

Biweekly dosing of teclistamab was defined by the FDA as a reduced dosing frequency of 1.5 mg/kg every 2 weeks among patients with R/R MM who have reached and maintained a complete response or better for at least 6 months. Johnson & Johnson authors explained, “There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.”

Teclistamab was originally approved by the FDA in October 2022, based on findings from the phase 1/2 single arm, multicohort, multicenter dose-escalation MajesTEC-1 trial (NCT03145181; NCT04557098), in which patients were initially treated with 1.5 mg/kg of teclistamab weekly subcutaneously—the recommended phase 2 dose. Patients who reached complete response or better for 6 months or longer were then able to reduce the dosing frequency to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity occurred. 

The findings of this trial regarding response rate led to the accelerated approval of teclistamab for adult patients with R/R MM who had received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

Regarding safety information, it was noted that the most frequently occurring adverse reactions, present in ≥ 20% of patients, were pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most frequently occurring grade 3 to 4 laboratory abnormalities, present in ≥ 20% of patients, were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. The authors encourage reading the full prescribing information, including the boxed warning, for teclistamab. 

“[Teclistamab] (TECVAYLI) is the only BCMA-targeted immune-based therapy with weight-based dosing. Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules,” stated Rachel Kobos, MD, Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. 

Source: 

TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma. PR Newswire - Johnson & Johnson. Published online: February 20, 2024. https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-us-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-302066627