U.S. FDA has approved Johnson & Johnson’s blood cancer therapy

Johnson & Johnson announced on Tuesday that the U.S. Food and Drug Administration (FDA) had approved its therapy for the treatment of a specific form of multiple myeloma, providing patients with the incurable blood cancer with yet another treatment option.

According to the company, Tecvayli, a brand name for J&J’s teclistamab, is approved for treating individuals with multiple myeloma that is difficult to treat or has returned after receiving four or more prior lines of certain types of therapies. According to a company representative, the therapy will go on sale around November 4 and will have a list price of $39,500 each month. The total cost would be between $355,000 and $395,000 for a nine to ten-month course.

A bispecific antibody called Tecvayli is designed to cause the body’s immune system to focus on identifying and eliminating cancer cells. It is the first drug in its class to have multiple myeloma approval. However, the approval comes with a boxed warning for neurologic damage and cytokine release syndrome, a disease where the immune system reacts more aggressively than it should.

Other approved therapies for multiple myeloma include GSK Plc’s Blenrep and competitor Bristol-Myers Squibb’s Abecma, but many patients experience a relapse after stopping treatment, creating a major unmet need that pharmaceutical companies can capitalise on. The European drug regulator gave J&J’s therapy provisional approval in August.

Multiple myeloma is a common form of blood cancer that starts in the bone marrow and can spread throughout the body, although being rare compared to breast or prostate cancer. The company claims that more men than women are affected by the cancer, which is normally discovered in patients between the ages of 65 and 74. The American Cancer Society predicts that this year, close to 35,000 new instances of multiple myeloma would likely be diagnosed throughout the US.