The Food and Drug Administration (FDA) has approved Johnson & Johnson's therapy for treating a type of multiple myeloma, the company said on Tuesday, giving another treatment option to patients with the 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 company said.
A company spokesperson said the therapy, which will be available on or around Nov. 4, 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 10 month course.
Tecvayli is a bispecific antibody, which is engineered to redirect body's immune system to recognize and kill cancer cells. It is the first drug of its class to be approved for multiple myeloma.
The approval, however, comes with a boxed warning for cytokine release syndrome, a condition where the immune system reacts more aggressively than it should, and neurologic toxicity.
While there are other approved therapies for treating multiple myeloma such as Abecma from rival Bristol-Myers Squibb and GSK Plc's Blenrep, many patients see a relapse after stopping treatment, making it an area of significant unmet need that drugmakers can tap into.
J&J's treatment received conditional approval from the European drug regulator in August.
Though multiple myeloma is rare compared to breast or prostate cancer, it is a common type of blood cancer, which develops in the bone marrow and can spread throughout the body.
The cancer is typically diagnosed in people aged between 65 and 74 and affects more men than women, according to the company.
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.