J&J seeking first-line MM indication for Darzalex

Johnson & Johnson (NYSE:JNJ) submitted applications in both the U.S. and EU seeking to push Darzalex daratumumab into the first-line setting to treat multiple myeloma.

On Tuesday, the pharma said it submitted an sBLA to FDA and Type II variation application to EMA for Darzalex in combination with Velcade bortezomib, melphalan and prednisone (VMP) to treat newly diagnosed MM in patients who are ineligible for autologous stem cell transplantation (ASCT). J&J said it is seeking Priority Review for the sBLA...