Millennium and its parent company Takeda announced that the FDA has approved Velcade (bortezomib) for subcutaneous administration in the management of multiple myeloma and mantle cell lymphoma after at least one prior therapy. This approval was based on results from a randomized, Phase 3, open-label, international, non-inferiority trial conducted in 222 bortezomib-naive patients with relapsed multiple myeloma. The primary objective of the trial was to demonstrate that single-agent subcutaneous Velcade retained at least 60% of the overall response rate (ORR) after four cycles relative to single agent intravenous Velcade.
Patients receiving Velcade subcutaneously achieved a 4-cycle ORR of 43% and complete response (CR) rate of 7%, while patients receiving Velcade intravenously achieved an ORR of 42% and a complete response rate of 8%. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, 6% of patients experienced PN of grade 3 or higher, compared with 16% in the intravenous arm. In the subcutaneous arm, 38% of patients experienced PN of all grades, compared with 53% of patients in the intravenous arm.
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