Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma

Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.

The FDA has granted accelerated approval for Johnson & Johnson’s Tecvayli (teclistamab-cqyv) to treat adult patients with relapsed or refractory multiple myeloma. Tecvayli is a first-in-class, bispecific T-cell engager antibody to treat patients who have previously received four or more prior lines of therapy. A bispecific antibody can bind to two different targets on two different cells at the same time. Tecvayli is an off-the-shelf therapy that targets the CD3 receptor expressed on the surface of T-cells and the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells.

Tecvayli will be available around Nov. 4, 2022. and will be available through a risk management program. It is supplied as 30 mg/3mL and 153 mg/1.7mL single-dose vials. The list price for Tecvayli is about $39,500 per month, according to a J&J spokesperson. In the clinical trial, the average patient was treated for 9 to 10 months. Based on this, the total cost of therapy ranges between a list price of $355,000-$395,000, the spokesperson said.

Multiple myeloma is an incurable blood cancer that affects plasma cells, which are found in the bone marrow. In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the United States.

“In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma,” Ajai Chari, M.D., professor of medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai and study investigator, 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.”

The approval was based on the pivotal phase 2 MajesTEC-1 clinical trial. Data from this trial were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June. These results from the MajesTEC-1 study were also simultaneously published online in The New England Journal of Medicine.

An overall response rate of 61.8% was achieved, with 28.2% of patients achieving a complete response or better. The median time to first response was 1.2 months (range 0.2 to 5.5 months). The most common adverse reactions in the safety population of MajesTEC-1 were pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

The label includes warnings about cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, in addition to warnings and precautions for hepatotoxicity, infections, neutropenia, hypersensitivity and other administrative reactions and embryo-fetal toxicity.

Additionally, Tecvayli received European approval in August 2022.

This story was updated to include information from J&J.