FDA OKs J&J’s Darzalex for Multiple Myeloma
The US Food and Drug Administration has approved Janssen Biotech, Inc.’s Darzalex (daratumumab) injection for intravenous infusion for treating multiple myeloma in patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. Janssen Biotech is a Janssen Pharmaceutical Company of Johnson & Johnson.
Darzalex is a human anti-CD38 monoclonal antibody. CD38 is a surface protein that is expressed by most, if not all, multiple myeloma cells. Darzalex is believed to induce tumor cell death through multiple immune-mediated mechanisms of action in addition to apoptosis, in which a series of molecular steps in a cell lead to its death. Its approval comes two months after the biologics license application was accepted for priority review by the FDA in September 2015.The drug also received breakthrough therapy designation from the FDA for this indication in May 2013.
Source: Johnson & Johnson