US FDA Approves Tecvayli® (Teclistamab-cqyv) for Relapsed/Refractory Multiple Myeloma (RRMM)

On October 25, 2022, the US FDA granted accelerated approval to Tecvayli® (teclistamab-cqyv, Janssen Biotech, Inc.) for adult patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 4-lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Tecvayli® (teclistamab-cqyv) is a first-in-class, bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager antibody that is administered as a subcutaneous treatment.

According to Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, in a press release, “Multiple myeloma (MM) is a deadly disease with considerable unmet need, and teclistamab-cqyv is a promising new treatment option for all those who have faced multiple relapses.”

Tecvayli® (Teclistamab-cqyv) was assessed in MajesTEC-1, a single-arm, multi-cohort, open-label, multi-center study. The efficacy population consisted of 110 patients who had been previously treated with at least 3-therapies, including a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and had not been treated with prior BCMA-targeted therapy.

The overall response rate was noted 61.8% (95% CI: 52.1, 70.9). With a median follow-up of 7.4 months among responders, the approximate duration of response (DOR) rate was noted as 90.6% (95% CI: 80.3%, 95.7%) at six months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months.

The PI for Tecvayli® (teclistamab-cqyv) has a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among those who received Tecvayli at the recommended dose, CRS emerged in 72% of patients, neurologic toxicity in 57%, and ICANS in 6%. Grade 3 CRS emerged in 0.6% of patients and Grade 3/4 neurologic toxicity emerged in 2.4%.

Due to the risks of cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity, this medicinal product is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), named the Tecvayli REMS.

The most commonly reported side effects (≥20%) in the 165 patients were pyrexia, musculoskeletal pain, injection site reaction, CRS, fatigue, upper respiratory tract infection, headache, pneumonia, nausea, and diarrhea. 

The most commonly reported Grade-3/4 laboratory abnormalities (≥20%) were decreased white blood cells, decreased neutrophils, decreased platelets, decreased lymphocytes, and decreased hemoglobin. 

Tecvayli is supplied as 30 mg/3 mL (10 mg/mL) and 153 mg/1.7 mL (90 mg/mL) of teclistamab-cqyv in single-dose vials. The recommended dose of teclistamab-cqyv is 0.06 mg/kg via subcutaneous injection on Day-1’st, 0.3 mg/kg on Day-4’th, and 1.5 mg/kg on Day-7’th, followed by 1.5 mg/kg once in a week until the disease is progressive or unacceptable toxicity occurs.

Reference: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma