The FDA has approved a supplemental new drug application for bortezomib (Velcade), updating the label to include the subcutaneous administration in all indications approved for intravenous administration, ie, multiple myeloma and mantle cell lymphoma after at least one prior therapy.
The approval was based on results from a randomized, phase III, open-label, international, noninferiority trial conducted in 222 bortezomib-naive patients with relapsed multiple myeloma. The primary objective of the trial was to demonstrate that single-agent subcutaneous bortezomib retained at least 60% of the overall response rate after four cycles relative to single-agent intravenous bortezomib.
Patients receiving bortezomib subcutaneously achieved a four-cycle overall response rate of 43% and complete response rate of 7%, while patients receiving bortezomib intravenously achieved an overall response rate of 42% and a complete response rate of 8%. The overall safety profile was similar between the two arms. However, in the subcutaneous arm of the trial, 6% of patients experienced peripheral neuropathy of grade 3 or higher, compared with 16% in the intravenous arm.
The updated label also includes a contraindication for intrathecal administration of bortezomib. ■