Velcade approved for subcutaneous administration


Millennium and Takeda Pharmaceutical together announced that the US Food & Drug Administration has approved a supplemental new drug application for their lead oncology product Velcade (bortezomib) to update the drug's label to include subcutaneous administration along with the current intravenous administration for all approved indications (first line therapy for multiple myeloma and for mantle cell lymphoma following at least one previous therapy).

FDA approval came on the heels of data published in the Lancet in May of 2011 showing results from a randomized, phase III, open-label, international trial conducted in 222 bortezomib-naïve patients with relapsed multiple myeloma.

You can read the specifics of the trial data at BusinessWire.

Illustration of the proteasome inhibitor bortezomib bound to an assembled yeast proteasome core (PDB ID 2F16). The bortezomib molecule is colored by atom (cyan = carbon, blue = nitrogen, red = oxygen), and the surrounding protein binding pocket colored by local secondary structure (red = helix, green = loop, yellow = sheet). The blue sidechain and surface region represents the catalytic threonine residue.

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