FDA OKs Millennium's Velcade Injection
CAMBRIDGE, Mass. (
) --U.S. regulators approved Monday a new formulation of
Takeda's
multiple myeloma drug Velcade that doctors can administer as a shot under the skin instead of as an intravenous infusion.
The new subcutaneous version of Velcade is both easier to administer and may also reduce nerve pain and numbness that is the most bothersome side effect of the multiple myeloma drug.
Takeda markets Velcade through its
Millennium Pharmaceuticals
subsidiary. The drug competes primarily against
Celgene's
(CELG) - Get Report
Revlimid although newer multiple myeloma medicines, including
Onyx Pharmaceutical's
(ONXX)
carfilzomib, are undergoing regulatory review. Carfilzomib, in particular, is designed to cause less nerve pain and numbness, known as peripheral neuropathy.
In a phase III study, 6% of multiple myeloma patients treated with injectable Velcade experienced severe peripheral neuropathy compared to 16% of patients treated with the older IV-infused Velcade. Overall, 38% of patients treated with injectable Velcade experienced periperhal neuropathy of all grades compared to 53% of patients in the intravenous arm.
Tumor response rates between both forms of Velcade were similar, although one-year survival rates were slightly higher for the older version of the drug compared to the newly approved injectable.
Velcade was initially approved in 2003. The drug recorded 2010 U.S. sales of $593 million.
--Written by Adam Feuerstein in Boston.
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