Alicia Mundy of the Wall Street Journal reports:
“Federal officials Tuesday questioned companies that make six cancer drugs about their failure to complete follow-up studies they promised to conduct in exchange for accelerated approval.”
The story reminds readers why these promised follow-up studies are essential:
“The meeting took place in the shadow of a recent announcement by the FDA that it intends to revoke the accelerated approval of the blockbuster drug Avastin for use in treating breast cancer, a move that has jolted the industry and provoked outrage among many women across the country who have asked Congress to intervene.
The FDA said follow-up studies by Avastin maker Genentech, a unit of Roche Holding AG, failed to show that the drug significantly delays the spread of tumors in breast-cancer patients.”