Regulatory Decision Summary for Tecvayli (teclistamab)

The purpose of the submission is to seek a marketing authorization with conditions for Tecvayli for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

After evaluation of the submitted data package, Health Canada authorized, with conditions, Tecvayli for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Authorization was based on a single-arm, Phase 1/2, open-label, multicentre study MajesTEC-1. Patients (n = 110) with relapsed and refractory multiple myeloma (r/r MM) who had received at least three prior lines of anti-myeloma therapy, including a proteasome inhibitor (PI), an immunomodulatory (IMiD) agent and an anti-CD38 antibody received Tecvayli 1.5 mg/kg actual body weight administered subcutaneously once weekly, preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg.

Efficacy results were based on overall response rate (ORR) as determined by the Independent Review Committee (IRC) assessment. The ORR was 61.8% with 28.2% of patients achieving a complete response (CR) or better. The median duration of response (DOR) was not estimable. At a follow-up analysis (including 15 additional patients enrolled since the primary analysis), the ORR was 62.4%, and the median DOR was 14.9 months. The high ORR is supported by the durability of the response. These efficacy results are considered promising evidence of clinical benefit for Tecvayli. The survival benefit of Tecvayli has not been established and is to be confirmed in an ongoing Phase 3 clinical trial.

The safety of Tecvayli was evaluated in 165 adult patients with r/r MM. Adverse reactions reported in ≥20% of patients were hypogammaglobulinemia, cytokine release syndrome (CRS), neutropenia, musculoskeletal pain, fatigue, thrombocytopenia, injection site reaction, upper respiratory tract infection, lymphopenia, diarrhea, pneumonia, nausea, pyrexia, headache, cough, constipation and pain. Serious adverse reactions that could be life-threatening or fatal included CRS and neurologic toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) were reported. These safety findings and the applicable risk mitigation measures are adequately described in the final Tecvayli Product Monograph (PM).

Overall, based on the evidence reviewed, the anticipated benefit outweighs the potential risks for Tecvayli for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a PI, an IMiD agent and an anti-CD38 antibody, and who have demonstrated disease progression on the last therapy.

The recommended dose of Tecvayli is 1.5 mg/kg actual body weight administered subcutaneously once weekly, preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg. Patients should be treated with Tecvayli until disease progression or unacceptable toxicity.

Health Canada granted this submission advanced consideration under the NOC/c policy.

For further details, please refer to the PM, approved by Health Canada and available through the Drug Product Database.