Janssen has announced EU approval of Darzalex (daratumumab) for use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for newly diagnosed myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT).
The approval is based on results of the ALCYONE clinical trial which showed that adding Darzalex to VMP reduces the risk of disease progression by 50%. The median progression free survival (PFS) for daratumumab-VMP had not yet been reached, compared to an estimate of 18.1 months for patients who received VMP alone.
This approval is important for myeloma patients as providing a treatment that shows a durable response often gives the best chance at lasting remission.
More details on the clinical trial can be found here.