The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for bortezomib (Velcade?, Millennium: The Takeda Oncology Company)) for Injection, which updates the label to include additional long-term (median follow-up 60.1 months) overall survival (OS) data from the VISTA trial. The landmark VISTA trial examined the use of bortezomib-based therapy in patients with previously untreated multiple myeloma (MM).
The 5-year follow-up data demonstrated that patients treated with bortezomib, melphalan and prednisone (VcMP) continued to have a statistically significantly longer OS (median OS 56.4 versus 43.1 months, p<0.05) than those treated with melphalan and prednisone (MP) alone, a recognized standard of care. These results translated into a 43.9% improvement in OS when patients received the bortezomib containing regimen. A complete data set from the trial will be presented at the upcoming meeting of the American Society of Hematology in San Diego, CA.
Statistically significant OS advantage
An earlier analysis (median follow-up of 36.7 months), demonstrated that starting with the bortezomib combination (VcMP) provided a statistically significant OS advantage over MP that was not regained despite the use of subsequent therapies including bortezomib-based regimens.
The VISTA trial is the largest Phase III registration study to report long-term OS in previously untreated multiple myeloma patients. This multicenter, international 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM who were not eligible for stem cell transplantation. The safety profile of bortezomib in combination with MP was consistent with the known safety profiles of both bortezomib and MP. This study was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development (J&JPRD).
The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with bortezomib is not recommended.
Bortezomib is approved for the treatment of patients with multiple myeloma. The drug is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.