FDA Approves Bortezomib Injectable for Multiple Myeloma and MCL

FDA

The FDA has approved Boruzu, a new presentation of bortezomib (Velcade) that allows for ready-to-use, subcutaneous or intravenous administration. The agent reduces the compounding preparation steps usually needed to administer the reference product.¹

The injectable is a proteasome inhibitor that will be leveraged for use in patients with multiple myeloma and mantle cell lymphoma; it references Velcade, which is a lyophilized powder that requires reconstitution prior to use.

The recommended starting dose for the agent is 1.3 mg/m²; it can be given intravenously at a concentration of 1 mg/mL or subcutaneously at a concentration of 2.5 mg/mL.² Patients with multiple myeloma can be considered for retreatment if they had a prior response to the agent and relapsed at least 6 months following completion of that prior treatment. When administered intravenously, the injection should be given as a 3 to 5 second bolus intravenous injection, according to the regulatory agency.

"We are building a distinct branded oncology injectable portfolio. The approval of Boruzu is our fourth 505(b)(2) injectable approval this year," Sean McGowan, vice president of Biosimilars and Branded Oncology, stated in a news release.¹ "These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients."

The most common toxicities experienced with the injectable in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia.

References

1. Amneal and Shilpa announce US FDA approval of BORUZU, the first ready-to-use version of bortezomib for subcutaneous administration. News release. Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited. September 5, 2024. Accessed September 6, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-and-Shilpa-Announce-U.S.-FDA-Approval-of-BORUZU-the-First-Ready-to-Use-Version-of-Bortezomib-for-subcutaneous-administration/default.aspx
2. Boruzu (bortezomib injection). Prescribing information. Shilpa Medicare Limited; 2024. Accessed September 6, 2024. https://amneal.com/wp-content/uploads/2024/08/Shilpa-Bortezomib-PI.pdf