Johnson & Johnson’s blood cancer therapy gets US FDA approval

The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s therapy for treating a type of multiple myeloma, the company said yesterday, 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 4th November, 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 bi-specific antibody, which is engineered to redirect body’s immune system to recognise 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’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.

Edits by EP News Bureau