About the API
Bortezomib is the first drug of its type – a proteasome inhibitor. It is used for the treatment of multiple myeloma (MM), a blood cancer, and mantle cell lymphoma (MCL), a rare type of non-Hodgkin’s lymphoma. In MM, its use includes retreatment for patients who had previously responded to treatment with bortezomib and relapsed at least six months after completing prior bortezomib treatment.
In clinical trials, the addition of bortezomib to other drugs was shown to improve overall survival in MM patients. In MCL, the use of a bortezomib-containing combination resulted in statistically significant prolongation of progression-free survival compared to use of a standard (R-CHOP) regimen.
Bortezomib is available for intravenous or subcutaneous use.
Co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies, bortezomib was approved by the FDA in 2003 for the treatment of patients with myeloma, though not as a first-line drug. Since then, it has been approved for initial treatment of multiple myeloma and mantle cell lymphoma. It was also approved for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least six months following completion of prior bortezomib treatment. It is synthesized through a multi-step chemical process.