FDA digest from June discussing warning labels, pancreatic treatment choices, and the quest for a lymphoma drug.
The number of adverse drug events (ADEs) disclosed on prescription drug labels has increased dramatically, with oncology-hematology medicines averaging 76 ADEs per label, according to an analysis by researchers from the Regenstrief Institute and the Indiana University School of Medicine (Arch Intern Med. 2011;171:944-946.doi:10.1001/archinternmed.2011.182).
ADEs for oncology-hematology drugs ranged from 15 to 273 per label. Across all specialties, the average label contained 70 different ADEs, with more commonly prescribed drugs averaging approximately 100 side effects.
The researchers called for less complexity, noting that, “While a high number of labeled ADEs is not necessarily indicative of a drug’s true toxicity, the presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”
The FDA approved sunitinib (Sutent) for the treatment of patients with unresectable, locally advanced, or metastatic pancreatic neuroendocrine tumors (pNETs). Sunitinib joins everolimus (Afinitor), approved for pNET earlier this month, as the first new treatments for the rare disease in nearly 30 years. The manufacturer, Pfizer Inc, said sunitinib is already approved for a pNET indication in Europe and 9 other countries. http://tiny.cc/chiw8
Cell Therapeutics, Inc said the FDA has agreed to meet in June to discuss the resubmission of an accelerated new drug application (NDA) for pixantrone, a novel aza-anthracenedione under investigation as a treatment for relapsed or refractory aggressive non-Hodgkin lymphoma. The company is appealing the agency’s finding last year that another clinical trial was needed for the NDA to move forward. www.celltherapeutics.com