Drugs Pharma

J&J gets FDA approval for therapy to treat blood cancer


HQ Team

October 26, 2022: Johnson & Johnson has got approval for its therapy to treat multiple myeloma, a type of blood cancer, from the US Food and Drug Administration (FDA), the company said on Tuesday.

J&J’s teclistamab, branded as Tecvayli, is approved for treating adults with multiple myeloma that is hard to treat.

A company spokesperson said the therapy, which will be available from the first week of November will be priced at $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 T-cell antibody and is administered as a subcutaneous treatment. It activates the immune system by binding to the receptors on the T-cells and to the B-cell maturation antigen (BCMA) found on the cancerous myeloma cells. It is the first drug of its class to be approved for multiple myeloma.

“We are greatly encouraged by the FDA’s approval of teclistamab and Janssen’s commitment to the multiple myeloma community,” said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation. “Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses.”

Tecvayli demonstrated an overall response rate of more than 60 per cent in heavily pretreated patients, according to Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development. 

J&J’s Tecvayli has already received conditional approval from the European drug regulator in August.

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.

There are some other therapies in the market for treating multiple myeloma such as Bristol-Myers Squibb’s Abecma and GSK Plc’s Blenrep. But these medicines have seen limited success, with most patients relapsing after the treatment is stopped.

Multiple myeloma is a common type of blood cancer typically diagnosed in adults aged between 65 and 74 and affects more men than women.

Multiple myeloma affects about 7 people out of 100,000 people each year. Healthcare providers estimate about 100,000 people in the United States have multiple myeloma.

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