NEW BRUNSWICK, N.J. – A Johnson & Johnson drug has won approval for treating the blood cancer multiple myeloma in patients who’ve failed three prior therapies and have few options.
Darzalex (DAR’-zah-lecks) is the first biologic drug and first monoclonal antibody — a genetically engineered drug designed to target diseased tissue and spare healthy cells nearby — approved for multiple myeloma. Darzalex helps certain immune system cells attack cancer cells by binding to a protein on their surface.
The Food and Drug Administration granted accelerated approval based on two small studies that showed Darzalex reduced or eliminated tumors in about one-third of patients for about seven months, on average. J&J’s Janssen biologic drug unit is conducting further testing.
For patients who respond to Darzalex, a year’s treatment costs $134,550, excluding discounts negotiated by payers.