FDA Approves Tecvayli for Relapsed/Refractory Myeloma

The Food and Drug Administration (FDA) granted an accelerated approval to Tecvayli (teclistamab-cqyv) for the treatment of adults with relapsed or refractory multiple myeloma who received four or more previous treatments, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD30 monoclonal antibody.

The FDA's approval of Tecvayli is based off findings from the MajesTEC-1 clinical trial, which showed that 61.8% of patients with relapsed or refractory multiple myeloma achieved a response to treatment.

According to the FDA, this drug is the first BCMA-directed CD3 T-cell engager approved for this patient population. The drug works by binding to certain types of T cells, which find and attack the cancer.

The approval is based off findings from the MajesTEC-1 clinical trial, which included 110 previously treated patients with relapsed or refractory myeloma who all received treatment with Tecvayli.

The main goal of the study was to determine overall response rate, which is the percentage of patients who see their disease shrink or disappear because of treatment. Findings showed that the overall response rate was 61.8%.

Further, among patients whose disease responded to Tecvayli, 90.6% had a response that lasted six months, and 66.5% had a response that lasted nine months.

The most common side effects from Tecvayli that were observed in at least 20% of patients on the study included: fever, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia and diarrhea.

The most common moderate to severe laboratory abnormalities were decreased lymphocytes, neutrophils, white blood cells, hemoglobin and platelets.

Tecvayli comes with a Boxed Warning for life-threatening cytokine release syndrome, a condition where the body releases too many inflammatory proteins called cytokines, as well as neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).

Seventy-two percent of patients on the study who received Tecvayli experienced cytokine release syndrome, while 57% experienced neurotoxicity. Six percent experienced ICANS. However, severe (grade 3) cytokine release syndrome was far less common, occurring in 0.6% of patients, as was severe (grade 3 or 4) neurologic toxicity, occurring in 2.4% of patients.

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