The U.S. Food and Drug Administration (FDA) has approved a new presentation of bortezomib (Boruzu) for ready-to-use subcutaneous or intravenous administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.
Bortezomib, a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This new product references a version of bortezomib involving a lyophilized powder requiring reconstitution before use (Velcade).
The most commonly reported adverse reactions for ready-to-use bortezomib in clinical studies included asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Full prescribing information is available for the new version of the agent.
Shilpa Medicare Limited developed the molecule, and Amneal Pharmaceuticals, Inc will manufacture and commercialize the product. The new presentation is expected to launch with a unique J-code in the second quarter of 2025.
