UPDATE 2-FDA OKs subcutaneous use of Takeda cancer drug

Mon Jan 23, 2012 5:46pm EST

* Less peripheral neuropathy seen with subcutaneous Velcade

* Treats multiple myeloma, mantle cell lymphoma (Adds sales, background, physician comment)

Jan 23 (Reuters) - Takeda Pharmaceutical Co said on Monday that U.S. health regulators gave a green light for the Japanese drugmaker's Velcade cancer drug to be administered by subcutaneous injection.

Velcade, which is approved by the Food and Drug Administration to treat multiple myeloma and mantle cell lymphoma, was previously only given via intravenous infusion.

In clinical trials, subcutaneous administration, or injections just under the skin, led to fewer incidence of peripheral neuropathy than the intravenous version of the drug. Peripheral neuropathy is a type of nerve damage that typically causes pain in the feet and legs.

Safety and efficacy of the two methods of Velcade administration were otherwise similar, the company said.

"Considering this new subcutaneous route of administration for Velcade is important for our patients, including those with poor vein access and those with pre-existing peripheral neuropathy or a high risk of developing peripheral neuropathy," Dr. Noopur Raje, director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, said in a statement.

Velcade was originally developed my Millennium Pharmaceuticals, which is now Takeda's oncology unit. Sales of the drug approached $600 million in the United States in the most recent fiscal year for Takeda. Johnson & Johnson sells Velcade outside the United States, although the companies have a co-promotion deal in Japan. (Reporting by Vidya P L Nathan in Bangalore and Bill Berkrot in New York; Editing by Gopakumar Warrier and Tim Dobbyn)

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