The US Food and Drug Administration (FDA) has granted priority review to Millennium Pharmaceuticals' Velcade in patients with newly diagnosed multiple myeloma (MM)
The supplemental New Drug Application (sNDA) submitted to the FDA for this indication included data from the phase III VISTA study, a large, well-controlled international clinical trial, comparing a Velcade based regimen to a traditional standard of care. Velcade is the market-leader for MM 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, M.D., chief medical officer, 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 ten to six months.
The VISTA trial randomised 682 patients with newly diagnosed MM ineligible for stem cell transplantation and was conducted by the company and its co- development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The trial compared VELCADE, melphalan and prednisone (VcMP) to the standard regimen of melphalan and prednisone (MP) alone. VcMP achieved a statistically significant improvement across all efficacy endpoints, including complete remission (CR) rates, time-to-disease progression (TTP) and survival (progression-free survival and overall survival). Included in these results, VcMP demonstrated an immunofixation-negative CR rate of 35 per cent, which is the highest rate reported in a phase III trial in patients with newly diagnosed MM, compared to 5 per cent in the MP arm.