Janssen’s Darzalex Approved for Multiple Myeloma

Janssen won FDA approval for Darzalex (daratumumab) in combination with bortezomib, thalidomide, and dexamethasone (VTD) to treat newly diagnosed patients who are eligible for autologous stem cell transplant.

The approval was based on results of a phase 3 clinical trial which showed that treatment with Darzalex resulted in a 53 percent reduction in the risk of progression or death compared to VTD alone.

The recommended dose is 16 milligrams per kilogram of body weight. The FDA granted daratumumab a priority review.