- Johnson & Johnson's Darzalex (daratumumab) has been approved by the FDA for the treatment of patients with multiple myeloma who have received at least three prior treatments.
- Darzalex is the first approved monoclonal antibody for the treatment of multiple myeloma.
- Based on current estimates, the first year of treatment will cost $135,550 and the second year of treatment will cost $76,044.
Darzalex was approved four months ahead of its PDUFA date as a drug with FDA-granted Breakthrough Designation. In one study of patients who had become resistant to treatment with other drugs, the overall response rate to Darzalex was 36%—a laudable response rate given the treatment realities associated with advanced multiple myeloma.
The need for treatment options is there. According to the National Cancer Institute, this year roughly 26,850 people will be diagnosed with multiple myeloma and 11,240 will die.
Darzalex has been a hotly-anticipated drug since Janssen released data at this year's American Society of Clinical Oncology (ASCO) meeting over the summer, where J&J announced that the therapy elicited responses in patients who had tried as many as five prior treatments, including Celgene's blood cancer blockbuster Revlimid, Amgen's Kyprolis, and J&J's own Velcade.