On September 2, Millennium: The Takeda Oncology Company reported that the company’s supplemental new drug application (sNDA) has been accepted for review by the U.S. Food and Drug Administration. The acceptance is based on the long-term overall survival data from the VISTA Phase 3 clinical trial that examined the use of Velcade (bortezomib) for treatment of previously-untreated multiple myeloma.

The VISTA trial compared a drug regimen of Velcade, melphalan (Alkeran), and prednisone with a drug regimen of melphalan and prednisone without Velcade in patients with previously untreated myeloma. The multicenter, international trial enrolled 682 patients with newly diagnosed myeloma who were ineligible for stem cell transplantation. The Velcade-enhanced regimen demonstrated a statistically significant improvement in complete response, overall response, progression-free survival, and overall survival.

"This is the largest Phase 3 registration study to report long-term overall survival in previously untreated multiple myeloma patients," said Nancy Simonian, the Chief Medical Officer of Millennium, in the Millennium press release. "This submission of data from the pre-planned long-term survival assessment represents an important milestone in the development of Velcade."

For more information, please read the Millennium press release.