FDA Approves Teclistamab-cqyv as First Bispecific T-cell Engager Antibody for Treatment of Patients With Relapsed or Refractory Multiple Myeloma

The indication is approved under accelerated approval based on response rate, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The FDA has approved teclistamab-cqyv (Tecvayli, Janssen) for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 4 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.

Teclistamab-cqyv is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment, and the ready to use therapy uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

The indication is approved under accelerated approval based on response rate, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

"Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses," said Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, in a press release.

The phase 2 MajesTEC-1 clinical trial included patients who had received a median of 5 prior lines of therapy, and an overall response rate of 61.8% was achieved with 28.2% of patients achieving a complete response or better.

The study featured heavily pretreated patients, and 78% of patients received 4 or more prior lines of therapy. All patients were triple-class exposed, whereas 76% were triple-class refractory.

There is a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome and warnings and precautions for hepatotoxicity, infections, neutropenia, hypersensitivity, and other administrative reactions and embryo-fetal toxicity.

The most common adverse events seen in the safety population during the trial were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. Further, the most common grade 3 to 4 laboratory abnormalities were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Teclistamab-cqyv is available through a restricted program called Tecvayli™ Risk Evaluation and Mitigation Strategy, and it is supplied as 30mg/3mL and 153mg/1.7mL single-dose vials.

"In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma," study investigator Ajai Chari, MD, professor of medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai, said in a press release. "As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients."

REFERENCE

U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. PR Newswire. October 25, 2022. Accessed October 26, 2022. https://www.prnewswire.com/news-releases/us-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301659083.html