Darzalex daratumumab regulatory update

EMA’s CHMP recommended conditional approval of Darzalex daratumumab from Johnson & Johnson to treat relapsed and refractory multiple myeloma (MM) in adults whose disease worsened after previous treatment with a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). The recommendation was based on data from the Phase III SIRIUS (MMY2002) trial and the Phase I/II GEN501 trial. Conditional approval would require Genmab to submit data from 2 ongoing Phase III trials of Darzalex plus Revlimid lenalidomide and dexamethasone and Darzalex plus Velcade bortezomib and dexamethasone. Data from both trials are expected in 2H17. Genmab expects a final decision from the European Commission in 60-90 days. ...