Biotechnology company, Genmab, has announced that the US Food and Drug Administration (FDA) has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma.
Multiple myeloma
The supplemental biologics licence application (sBLA) for this indication — treatment of newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (ASCT) — was submitted by Genmab’s licensing partner Janssen Biotech. The FDA granted priority review of the sBLA and has a target date of 21 May 2018 for the Prescription Drug User Fee Act (PDUFA).
“With this label expansion, DARZALEX becomes the first antibody therapeutic to be approved for patients with newly diagnosed multiple myeloma,” said Jan van de Winkel, PhD, chief executive officer of Genmab. “This is an important step forward as it provides an additional treatment option to patients who are newly diagnosed with multiple myeloma.”
This approval was based on Phase III data (ALCYONE study) that demonstrated a decreased risk of disease progression or death by 50% in patients with newly diagnosed multiple myeloma ineligible for ASCT when daratumumab is combined with VMP.