FDA Approves Subcutaneous Dosing of Velcade (Bortezomib)

January 24, 2012

(Reuters) Jan 23 - Takeda said U.S. health regulators gave approval to market subcutaneous shots of its cancer drug Velcade (bortezomib).

Velcade, which is already approved as a treatment for multiple myeloma and mantle cell lymphoma, has so far been approved to be given as intravenous shots.

The new approval was based on results from a randomized phase 3 non-inferiority trial conducted in 222 bortezomib-naive patients with relapsed multiple myeloma.

In a press release issued by Takeda, Dr. Noopur Raje, director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, 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."

The updated label also includes a contraindication for intrathecal administration as fatal events have occurred with the inadvertent intrathecal administration of Velcade.