U.S. FDA Approves LIVMARLI (maralixibat) as…

Genentech, the South San Francisco-based unit of Roche, and its Berkeley, CA-based Plexxikon, a unit of Daiichi Sankyo, said today that the FDA has approved their new drug for certain patients with melanoma that has spread through the body. The FDA said the companies can now start selling vemurafenib (Zelboraf) for patients who have mutations of a protein called BRAF that is implicated in their melanoma. The drug, which showed startlingly positive results in clinical trials, was approved ahead of the FDA’s legal deadline of Oct. 28, an action the agency rarely takes.