Bortezomib Injectable Receives FDA Approval for Multiple Myeloma and MCL

Bortezomib Injectable Receives FDA Approval for Multiple Myeloma and MCL

Boruzu, a new presentation of bortezomib (Velcade) has been approved by the FDA to allows for ready-to-use, subcutaneous or intravenous administration in patients with multiple myeloma and mantle cell lymphoma. The agent reduces the compounding preparation steps usually needed to administer the reference product.

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.

"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. "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."

Reference

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