The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson’s (JNJ.N) therapy for treating a type of multiple myeloma, stated the company, giving another treatment option to patients with incurable blood cancer.
J&J’s teclistamab, branded as Tecvayli, is approved for treating adults with multiple myeloma that is hard to treat or has come back after receiving four or more prior lines of certain classes of therapies.
The therapy will have a list price of $39,500 per month, with the overall pricing ranging between $355,000 and $395,000 for a nine to the 10-month course.
Tecvayli is a bispecific antibody, which is engineered to redirect the body’s immune system to recognize and kill cancer cells. It is the first drug of its class to be approved for multiple myeloma.
However, the approval comes with a boxed warning for cytokine release syndrome, a condition where the immune system reacts more aggressively than it should, and neurologic toxicity.