The US Food and Drug Administration (FDA) granted priority review for bortezomib (Velcade) in patients with newly diagnosed multiple myeloma. The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the phase III VISTA study (Velcade as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), an international clinical trial comparing a bortezomib-based regimen to a traditional standard of care. Bortezomib is the market-leader for multiple myeloma and mantle cell lymphoma patients who have received at least one prior therapy.
"Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, MD, chief medical officer at Millennium. "The rapid action by the FDA puts us one step closer to establishing Velcade-based therapies as a standard of care for patients with newly diagnosed multiple myeloma."
Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from 10 to 6 months.
The VISTA trial randomized 682 patients with newly diagnosed mm ineligible for stem cell transplantation and was conducted by Millennium and its codevelopment partner Johnson & Johnson. The trial compared VcMP (bortezomib, melphalan [Alkeran], prednisone) to the standard MP regimen (melphalan and prednisone) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP), and survival (both progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35%, which is the highest rate reported in a phase III trial in patients with newly diagnosed multiple myeloma, compared to 5% in the MP arm.