A Johnson & Johnson (JNJ) unit said that the U.S. Food and Drug Administration has designated its investigational myeloma treatment daratumumab a “breakthrough therapy,” paving the way for its speedier development.
Janssen Research and Development LLC said the FDA granted the designation for daratumumab to treat patients with multiple myeloma who have received at least three prior lines of therapy outlined by the agency. Multiple myeloma is a form of cancer found in bone marrow.
The “breakthrough therapy” designation is used by the FDA to identify potential new treatments for serious or life-threatening diseases, for which the agency will take certain steps to speed development. The designation can also trigger closer involvement by senior FDA officials.
Daratumumab is an investigational antibody discovered by Danish company Genmab A/S (GEN.KO). Genmab and Janssen entered an agreement in Aug. 2012 allowing Janssen to develop and commercialize the drug.
Johnson & Johnson shares were off 46 cents to $84.77 in recent trading. The stock is up 21% since the start of the year.