Amneal and Shilpa's Boruzu (Bortezomib) Receives FDA Approval for Multiple Myeloma and Mantle Cell Lymphoma
Key Insights
Amneal Pharmaceuticals and Shilpa Medicare (search) have gained FDA approval for Boruzu (search), a ready-to-use bortezomib injection, for subcutaneous or intravenous administration.
Boruzu (search) simplifies oncology treatment by reducing preparation steps compared to Velcade, a lyophilized powder requiring reconstitution before use.
The drug, a proteasome (search) inhibitor, is approved for treating multiple myeloma (search) and mantle cell lymphoma (search), with a planned launch in Q2 2025.
Amneal Pharmaceuticals and Shilpa Medicare (search) have received FDA approval for Boruzu (search) (bortezomib injection), a ready-to-use formulation for treating multiple myeloma (search) and mantle cell lymphoma (search). This new formulation offers subcutaneous and intravenous administration options, reducing the preparation steps required compared to the current standard, Velcade.
Streamlining Bortezomib Administration
Boruzu (search) is a proteasome (search) inhibitor indicated for adult patients with multiple myeloma (search) and mantle cell lymphoma (search). Unlike Velcade, which is a lyophilized powder requiring reconstitution, Boruzu is ready-to-use, potentially saving time and reducing the risk of errors in preparation. Sean McGowan, Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals, stated that these ready-to-use injectable presentations are important innovations for oncology providers as they reduce pharmacy preparation steps for clinicians.
Clinical Profile and Adverse Reactions
Clinical studies evaluating Boruzu (search) reported common adverse reactions including asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. These adverse events are consistent with those observed with bortezomib treatment. Patients with pre-existing severe neuropathy should be treated with bortezomib only after a careful risk-benefit assessment.
Market and Launch
According to IQVIA, U.S. annual sales for bortezomib were approximately $96 million for the 12 months ended December 2023. Amneal plans to launch Boruzu (search) with a unique J-code in the second quarter of 2025. Vishnukant Bhutada, Managing Director of Shilpa Medicare (search), noted that this approval demonstrates their commitment to introducing pharmacy-efficient solutions that enhance preparation and have the potential to reduce patient wait times.
Mechanism of Action
Bortezomib functions as a proteasome (search) inhibitor, blocking the action of proteasomes, which are large protein complexes responsible for degrading unneeded or damaged proteins. By inhibiting proteasomes, bortezomib leads to an accumulation of intracellular proteins, disrupting normal cellular function and inducing apoptosis in cancer cells. This mechanism is particularly effective in treating multiple myeloma (search) and mantle cell lymphoma (search), where cancer cells are more sensitive to proteasome inhibition.