A roundup of FDA news from May 2013
The FDA has approved radium Ra 223 dichloride (Xofigo) for the treatment of castration-resistant prostate cancer that has metastasized only to the bones. Xofigo, an intravenous injection of the radioactive material radium 223, binds with bone minerals to deliver radiation directly to bone tumors, minimizing damage to surrounding healthy tissue. The drug was approved more than 3 months ahead of the goal date of August 14, 2013, under the FDA's priority-review program.
The FDA also granted approval to two new agents as well as a companion diagnostic test, all targeted toward the treatment of metastatic or unresectable melanoma:
• Dabrafenib (Tafinlar), a BRAF inhibitor, is intended for persons with melanoma tumors that express the BRAF V600E gene mutation.
• Trametinib (Mekinist), is an MEK inhibitor to be used in persons whose melanoma tumors express the BRAF V600E or the V600K mutations.
• A novel molecular test called THxIDTM-BRAF was approved along with dabrafenib and trametinib. This companion diagnostic test will help determine whether late-stage metastatic melanoma tumor samples from a given patient carry the BRAF V600E or the BRAF V600K mutation.