With an estimated duration of response rate of 90.6% at six months and 66.5% at nine months in the agent’s clinical trials, in October 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli™) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least four previous lines of therapy.
Bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager
Mechanism of Action
Teclistamab-cqyv binds to the CD3 receptor expressed on the surface of T cells and BCMA expressed on the surface of MM cells and some healthy B-lineage cells. The activated T cells release cytokines, resulting in MM cell lysis.
Adults with relapsed or refractory MM who have received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody
Teclistamab-cqyv uses a step-up dosing schedule:
- Day 1: 0.06 mg/kg (step-up dose 1)
- Day 4: 0.3 mg/kg (step-up dose 2)
- Day 7: 1.5 mg/kg (first treatment dose)
- Weekly thereafter: 1.5 mg/kg until patients experience disease progression or unacceptable toxicity
Administer teclistamab-cqyv via subcutaneous injection, preferably in the abdomen. Other sites such as the thigh may be used if necessary. If multiple administration sites are needed for a single dose, space injections at least 2 cm apart. Do not exceed 2 ml for each injection.
Administer premedications one to three hours before each step-up dose and the first treatment dose, including a corticosteroid (oral or IV dexamethasone 16 mg), H1 receptor antagonist (oral or IV diphenhydramine 50 mg or equivalent), and an antipyretic (oral or IV acetaminophen 650–1,000 mg or equivalent).
Teclistamab-cqyv has a black box warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS). Other warnings include hepatotoxicity, infection, neutropenia, embryo-fetal toxicity, hypersensitivity, and other administration reactions.
More than 20% of patients in the drug’s clinical trials experienced pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reactions, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, or diarrhea. The most common grade 3 and 4 laboratory abnormalities in more than 20% of patients were decreased lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.
Teclistamab-cqyv is available only through a restricted REMS program. Monitor patients closely for signs of CRS and neurologic toxicity and ensure that emergency management measures are available. Because of the risk for CRS and neurologic toxicity, patients are hospitalized and observed for 48 hours after administration during the step-up dosing schedule. Patients who experience CRS with a prior dose or are repeating doses after a delay may require premedication for subsequent doses. Some patients may require antiviral prophylaxis for herpes zoster reactivation prior to starting treatment. Verify pregnancy status prior to teclistamab-cqyv treatment.
Advise patients of the necessity for hospitalization during and following step-up dosing and to monitor for signs of adverse reactions. Provide patients with a wallet card to inform other healthcare providers about their teclistamab-cqyv treatment and the signs and symptoms of CRS and neurologic toxicity.
Patients of reproductive potential should use effective contraception during treatment and for five months after the last dose. Breastfeeding is not advised during treatment and for five months after the last dose. Teclistamab-cqyv may suppress cytochrome P450 enzymes activity and increase exposure to CYP substrates; monitor patients closely for toxicity.
Teclistamab-cqyv can cause embryo-fetal harm. Follow proper handling and disposal procedures.
Call 844-628-1234 for information about patient support.