Bortezomib (Vanco) Subcutaneous Delivery Approved by FDA

Results from an international, randomized, multicenter phase III clinical trial in patients with multiple myeloma, published in Lancet Oncol. 2011 Jun;12(6):522, showed that subcutaneous administration of bortezomib was comparable in efficacy and better in safety than standard intravenous administration. Patients with relapsed multiple myeloma who had received 1-3 lines of prior therapy were randomized to receive either subcutaneous or intravenous bortezomib (1.3 mg/m2, days 1, 4, 8, 11, every 21 days). After 4 cycles of treatment, the 2 modes of administration demonstrated similar efficacy (43% overall remission rate and 8% complete remission rate), but only 6% of patients in the subcutaneous dosing group developed grade 3 or greater peripheral neuropathy, compared with 16% in the intravenous dosing group. An additional 38% of patients in the subcutaneous group developed neuropathy of any grade, compared with 53% in the intravenous group.