Johnson & Johnson (JNJ +0.6%) unit Janssen-Cilag International NV files a Type II variation application with the European Medicines Agency seeking approval to use DARZALEX (daratumumab), in combination with Takeda's VELCADE (bortezomib), melphalan and prednisone, to treat adult patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplantation.
The data supporting the filing was generated in the Phase 3 ALCYONE study.
READ FULL ARTICLE HERE