July 2010 Issues

FDA Advisory Panel Recommends the FDA Pull Avasitin's Metastatic Breast Cancer Indication -- Quick Pulse
Summary: The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted nearly unanimously that Roche/Genentech’s cancer drug Avastin (bevacizumab) should not keep its label for first-line metastatic breast cancer. The panel said the risk:benefit in two postmarketing trials were not favorable and did not confirm the original benefit seen in the E2100 trial, on which accelerated approval was granted, so regular approval should not be given.

FDA Advisory Panel to Review New Data on Roche/Genentech's Avastin in Breast Cancer -- Quick Pulse
Summary: On Tuesday, July 20, 2010, the FDA’s Oncology Drug Advisory Committee (ODAC) will meet to review whether Roche/Genentech’s cancer drug Avastin (bevacizumab) should keep its label for first-line metastatic breast cancer. The panel will consider whether Avastin met the requirements for accelerated approval for breast cancer, which was granted two years ago.

FDA's Council on Medical Device Innovation -- Quick Pulse
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) established a Council on Medical Device Innovation, and the panel met recently to hear from industry and public witnesses about ways the agencies can help spur device innovation in areas of unmet public health need. They heard a lot of complaints about unpredictable regulatory requirements imposed by the FDA and a lengthy CMS reimbursement process. There were few concrete suggestions relating directly to unmet medical needs. The docket will remain open until July 24, 2010, for additional comments.

The FDA's Proposed Opioid Risk Evaluation and Management Strategy (REMS) -- Quick Pulse
Summary: On June 28, 2010, the FDA surprised just about everyone by issuing what appears to be a rather weak REMS for long-acting (LA) and extended-release (ER) opioids, including morphine ER, oxymorphone ER, oxycodone ER, hydromorphone ER, fentanyl transdermal patches, and methadone. The draft proposal will be discussed on July 22 and 23, 2010, by a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

A Preview of the FDA Advisory Committee on GSK's Avandia -- Quick Pulse
Summary: On July 13 and 14, 2010, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, meeting jointly, will consider the cardiovascular (CV) safety of GlaxoSmith- Kline’s diabetes drug Avandia (rosiglitazone), a thiazolidinedione (TZD). The briefing documents and the slides for the meeting were released in advance, and overall the FDA is making a fairly balanced presentation to the panel, offering both sides of the issue.