Subcutaneous Bortezomib a New Therapeutic Option

February 2012, Vol 3, No 1

The FDA approved a new, subcutaneous route of administration for the proteasome inhibitor bortezomib (Velcade; Millennium) as an alternative method to the previously approved intravenous (IV) form of the drug in all the FDA indications. Bortezomib is indicated for the treatment of multiple myeloma (MM) and of mantle-cell lymphoma in patients who have received at least 1 previous therapy.

The FDA approval of bortezomib for injection is based on a randomized, phase 3, open-label, noninferiority trial in 222 bortezomib-naïve patients with relapsed MM. The study met its primary end point, to demonstrate at least 60% overall response rate with subcutaneous bortezomib relative to IV bortezomib. 

The overall safety profile was similar between the 2 forms of the drug, with the subcutaneous form showing reduced (6%) grade 3 peripheral neuropathy versus the IV form (16%). (January 23, 2012)

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