The U.S. Food and Drug Administration (FDA) has approved Millennium Pharmaceuticals' Velcade (bortezomib) for the retreatment of patients with multiple myeloma who had responded to treatment but had relapsed at least six months following treatment with Velcade. Velcade can be administered alone or in combination with dexamethasone. Velcade retreatment can be started at the last tolerable dose observed during initial treatment.
The FDA approved Velcade for retreatment based on the study, "A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma," or the RETRIEVE trial. Researchers found a 38.5% overall response rate in patients had been previously treated with bortezomib and had at least partially responded.
Researchers enrolled 130 patients into the study, 94 of which were assigned to receive bortezomib plus dexamethasone. One patient achieved a complete response while 49 patients achieved partial responses. The median duration of response was 6.5 months.
The most common adverse effect was thrombocytopenia (52%), which was consistent with previous studies of bortezomib. Peripheral neuropathy was observed in 28% of patients. Velcade was initially approved by the FDA in 2003 for the treatment of patients with multiple myeloma and later for patients with mantle cell lymphoma who have received at least one prior treatment.
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE® (bortezomib) for the retreatment of adult patients with multiple myeloma (MM) who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.
The labeling update includes dosing guidelines as well as safety and efficacy findings for the use of VELCADE as a single agent or VELCADE in combination with dexamethasone in patients previously treated with VELCADE.