Whoa….. we missed covering this FDA approval.
Way back in October the FDA approved a new subcutaneous treatment, Tecvayli from Janssen Biotech, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Tecvayli is a first-in-class, bispecific T-cell engager antibody engineered to redirect body’s immune system to recognize and kill cancer cells.
Multiple myeloma is typically diagnosed in people aged between 65 and 74 and affects more men than women. According to the American Cancer Society’s estimates, close to 35,000 new cases of multiple myeloma are likely to be diagnosed in the United States this year.
The approval, however, comes with a boxed warning and will only be available through a restricted program under a REMS called the Tecvayli REMS because of the risks of cytokine release syndrome, and neurologic toxicity, including ICANS.
Tecvayli is Janssen’s fourth approved treatment for multiple myeloma. A company spokesperson said the therapy will launch with a list price of $39,500 per month, with the overall pricing ranging between $355,000 and $395,000 for a nine-to-10-month course.
Janssen has not yet announced distribution plans. Given the cost and that Tecvayli is a sub-q therapy, it is expected that one or more specialty pharmacies will be selected for a Limited Distribution program.