Accelerated FDA approval for Janssen's Darzalex for previously treated multiple myeloma patients

Yesterday, the US Food and Drug Administration granted accelerated approval for US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech’s Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments.

Darzalex is the first monoclonal antibody approved for treating multiple myeloma. The US National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the USA this year.

“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, adding: “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”