• Opioids. Draft issued for opioid prescriber education program, as part of the Risk Evaluation and Mitigation Strategy (REMS) now in place for brand-name and generic long-acting and extended-release opioids.
• Pioglitazone. Bladder cancer warning risk added to the label for type 2 diabetes drug marketed as Actos (or in combination with metformin as Actoplus Met, and with glimepiride as Duetact).
• Romiplostim (Nplate for subcutaneous injection, Amgen, Inc.) and eltrombopag (Promacta tablets, GlaxoSmithKline LLC). Elements of the REMS for the two thrombopoietin receptor agonists were dropped, including the restricted distribution program that required health care professionals, hospitals, and patients to be enrolled in order to prescribe, dispense, or receive these drugs. Clinicians no longer need to file periodic safety forms for their patients on these treatments.
• Tumor necrosis factor (TNF) blockers. Manufacturers asked to report cases of malignancies in children, adolescents, and adults aged 30 years and younger treated with TNF blockers and to conduct in-depth follow-up of them.
OTHER ACTIONS
• Bevacizumab (Avastin, Genentech, Inc.). FDA Commissioner Margaret Hamburg withdrew bevacizumab’s indication in metastatic breast cancer. She cited a lack of data establishing benefit and serious risks associated with treatment. The decision followed a July hearing, where the Oncologic Drugs Advisory Committee unanimously voted that the indication be withdrawn despite emotional testimony from patients who said they benefited from the monoclonal antibody.
• Drug shortages. A new rule requires some manufacturers to give early warning of shortages. The agency also held a workshop on the crisis and is working to avert and/or resolve shortages.
• Office of Oncology Products. Many New Drug Applications, Biologic License Applications, and Investigational New Drug Applications for cancer drugs are being reassigned to new review divisions as part of a reorganization.