TECVAYLI

What it is

TECVAYLI is a humanised immunoglobulin G4-proline, alanine, alanine (IgG4-PAA) bispecific antibody targeting the B cell maturation antigen (BCMA) and CD3 receptors, produced in a mammalian cell line using recombinant DNA technology. TECVAYLI is a colourless to light yellow preservative-free solution for injection. It is available in two presentations: a 3 mL vial containing 30 mg of teclistamab (10 mg/mL) and a 1.7 mL vial containing 153 mg of teclistamab (90 mg/mL).

Approved indications —

Relapsed or refractory multiple myeloma in adult patients who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI has provisional approval in Australia based on overall response rate in a single arm study, and continued approval depends on verification and description of benefit in confirmatory trials.

Dosing overview

The recommended dosage of TECVAYLI is step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. In patients who have a complete response or better for a minimum of 6 months, a reduced dosing frequency of 1.5 mg/kg every two weeks until disease progression or unacceptable toxicity may be considered. TECVAYLI should be administered by subcutaneous injection only.

Key safety warnings

Cytokine release syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), can occur in patients receiving TECVAYLI. In the MajesTEC-1 study, the median time to onset of CRS was 2 days after the most recent dose with a median duration of 2 days. Clinical signs and symptoms may include fever, chills, hypotension, tachycardia, hypoxia, headache, and elevated liver enzymes. Potentially life-threatening complications may include cardiac dysfunction, adult respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation. The step-up dosing schedule reduces the incidence and severity of CRS, and patients must remain within proximity of a healthcare facility with daily monitoring for signs and symptoms for 48 hours after administration of all doses within the step-up dosing schedule. Serious, life-threatening or fatal neurologic toxicities, including ICANS, occurred following treatment with TECVAYLI. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Severe, life-threatening or fatal infections have been reported in patients receiving TECVAYLI. New or reactivated viral infections occurred during therapy. Progressive Multifocal Leukoencephalopathy (PML), which can be fatal, has been reported. If PML is suspected, withhold treatment and initiate appropriate diagnostic testing. Discontinue TECVAYLI if PML is confirmed. Hepatitis B virus reactivation can occur in patients treated with drugs directed against B cells, and in some cases may result in fulminant hepatitis, hepatic failure, and death. Patients with evidence of positive HBV serology should be monitored for clinical and laboratory signs of HBV reactivation while receiving TECVAYLI and for at least six months following the end of treatment. Hypogammaglobulinaemia has been reported in patients receiving TECVAYLI. Immunoglobulin levels should be monitored during treatment and managed according to local institutional guidelines, including infection precautions, antibiotic or antiviral prophylaxis, and administration of immunoglobulin replacement therapy. Neutropenia and febrile neutropenia have been reported. Complete blood cell counts should be monitored at baseline and periodically during treatment. Patients with neutropenia should be monitored for signs of infection.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

TECVAYLI was first approved on 14 June 2023. ARTG registrations were granted on 2023-06-14 for TECVAYLI teclistamab 10 mg/mL solution for injection vial (ARTG 387621) and TECVAYLI teclistamab 90 mg/mL solution for injection vial (ARTG 387622). TECVAYLI has provisional approval in Australia based on overall response rate observed in a single arm study, with continued approval depending on verification and description of benefit in confirmatory trials.