Takeda Gets FDA Approval For Velcade’s sNDA

Millennium has reported that the FDA has approved Takeda Oncology’s (Takeda) supplemental new drug application (sNDA) for Velcade, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from Vista1 trial and provides specific dosing recommendations for patients with hepatic impairment. The Vista trial examined the use of Velcade based therapy in patients with previously untreated multiple myeloma (MM).

The company has presented the updated survival data at the 51st Annual Meeting of the American Society of Hematology (ASH), confirmed the OS benefit observed at the original interim analysis that led to the front-line approval of Velcade in MM in June 2008. The follow-up data demonstrated that patients treated with Velcade, melphalan and prednisone (VcMP) continued to have longer OS than those treated with melphalan and prednisone (MP) alone.

These results translated into a 35% reduction in risk of death (hazard ratio 0.65). The OS benefit of VcMP was observed despite the use of subsequent therapies at relapse, including Velcade-based regimens.

The Vista phase III registration study reports long-term overall survival in previously untreated multiple myeloma patients. The multicenter, international 682-patient clinical trial compared VcMP to MP in patients with previously untreated MM, who were not eligible for stem cell transplantation.

However, in the original interim analysis of the Vista data, the VcMP arm demonstrated a positive improvement above the MP arm in time-to-disease progression (24 months vs. 17 months), complete response (35% vs. 5%), response rate (69% vs. 34%), progression-free survival (18.3 months vs. 14 months), and OS (hazard ratio 0.61) compared to the MP arm.

The FDA also reviewed other data derived from an ongoing National Cancer Institute (NCI) study. The analysis supported that patients with mild hepatic impairment did not require dose adjustments while patients with moderate or severe hepatic impairment should begin therapy with Velcade at a reduced dose and be closely monitored for toxicities.

Deborah Dunsire, president and CEO of Millennium, said: “Velcade has been shown to provide a significant long-term survival benefit for patients, and we are thrilled to have this prolonged survival data added to the prescribing information.”