USA —The Food and Drug Administration (FDA) has approved Johnson & Johnson’s B-Cell Maturation Antigen-CD3 (BCMA-CD3)-directed bispecific therapy for treating multiple myeloma, giving patients with the incurable blood cancer another treatment option.
The drug, Teclistamab marketed by J&J as Tecvayli has been shown to be effective in treating people with multiple myeloma who had previously failed therapies. This could help improve the prognosis (outcome) for many people with the disease.
Teclistamab is a bispecific antibody medication. It targets BCMA, a protein on myeloma cells, as well as CD3, a protein on T cells in the immune system. Teclistamab causes T cells to recognize and attack multiple myeloma cells.
BCMA has emerged as a promising therapeutic target for multiple myeloma. CAR T cell therapies, which genetically modify a patient’s own immune cells, have already demonstrated success in targeting the protein.
However, teclistamab has a significant advantage. It is administered subcutaneously unlike other preceding multiple myeloma treatments that are administered as intravenous infusions that can last up to an hour.
The approval, however, comes with a boxed warning for cytokine release syndrome, a condition in which the immune system overreacts, and neurologic toxicity.
While there are other approved therapies for multiple myeloma, such as Abecma from Bristol-Myers Squibb and GSK Plc’s Blenrep, many patients relapse after stopping treatment, indicating a significant unmet need that drugmakers can address.
These multiple myeloma therapies including J&J’s CAR-T Carvykti are normally administered to those patients who have received prior treatments including immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies.
Currently, all four BCMA drugs are in fifth-line treatment, but they hope to move up in the treatment order.
In the phase 3 MajesTEC-3 trial, J&J is combining Tecvayli with Darzalex in patients who have received one to three prior lines of therapy.
According to a company spokesperson, the therapy, which will be available on or around November 4, will have a list price of US$39,500 per month, with overall pricing ranging between US$355,000 and US$395,000.
Multiple myeloma is most commonly diagnosed in people aged 65 to 74, and it affects men more than women.
J&J’s treatment received conditional approval from the European drug regulator in August.