FDA Announces New Indications for Stivarga

On February 25, 2013 the U.S. Food and Drug Administration announced approval of Stivarga (regorafenib) for a new indication, to treat patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-Approved treatments for this condition. GIST is a tumor in which cancerous cells form in the tissues […]

FDA Approves Kadcyla For Late Stage Breast Cancer

On February 22, 2012 the U.S. Food and Drug Administration approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast […]

FDA Approves Pomalyst for Multiple Myeloma

On February 8, 2013 the U.S. Food and Drug Administration approved a new drug to treat multiple myeloma.  The drug, Pomalyst (pomalidomide) is approved for use in patients whose disease has progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from […]

FDA Approves Generic Version of Cancer Drug Doxil

On February 4, 2013 the U.S. Food and Drug Administration approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to […]