September 2005 Issues

FDA Oncologic Drugs Advisory Committee Recommends Approval of Revlimed for MDS - Quick Pulse

Summary: The FDA's Oncologic Drugs Advisory Committee voted 10-5 to approve Celgene's drug Revlimid (lenalidomide), an oral drug to treat anemia in patients with MDS (myelodysplastic syndrome), a potentially fatal blood disorder. FDA reviewers agreed Revlimid shows efficacy in reducing transfusion dependence, but they had several concerns with the drug.

FDA Advisory Committee Recommends Approval of Pancreatic Cancer Drug - Quick Pulse

Summary: The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-3 to recommend approval of OSI Pharmaceuticals/Genetech's Tarceva (erlotinib) in combination with Lilly's Gemzar (gemcitabine) for treatment of pancreatic cancer, despite concerns about marginal efficacy and severe toxicity.

FDA Advisory Committee Recommends Approval of Inhaled Insulin - Quick Pulse

Summary: The FDA's Endocrine and Metabolic Drugs Advisory Committee voted 7-2 to recommend approval of Pfizer's Exubera (insulin powder, rDNA origin, for oral-pulmonary inhalation), for the treatment of Type 1 and Type 2 diabetes, despite concern about the agent's pulmonary toxicity and decline in pulmonary function.

FDA Oncologic Drugs Advisory Committee Recommends Approval of Arranon to Treat Leukemia and Lymphoma - Quick Pulse

Summary: Nicotinic acetylcholine receptor agonists are a promising new class of drugs to treat cognition in schizophrenia and/or Alzheimer’s Disease, and there are a variety of them in development, but none have even shown proof-of-concept yet. ♦ Doctors were not very excited about the use of Cephalon’s modafinil in ADHD. ♦ Both Pfizer’s Geodon (ziprasidone) and AstraZeneca’s Seroquel (quetiapine) look promising in bipolar disorder. ♦ Novartis’s antipsychotic Clozaril (clozapine) was described as “vastly underutilized,” and safety may be better than previously thought. ♦ The FDA is urging sponsors to submit better and more complete new drug applications, and to respond quicker to the Agency’s safety questions.

New Clinical Drug Evaluation Unit (NCDEU)

Summary: Nicotinic acetylcholine receptor agonists are a promising new class of drugs to treat cognition in schizophrenia and/or Alzheimer’s Disease, and there are a variety of them in development, but none have even shown proof-of-concept yet. ♦ Doctors were not very excited about the use of Cephalon’s modafinil in ADHD. ♦ Both Pfizer’s Geodon (ziprasidone) and AstraZeneca’s Seroquel (quetiapine) look promising in bipolar disorder. ♦ Novartis’s antipsychotic Clozaril (clozapine) was described as “vastly underutilized,” and safety may be better than previously thought. ♦ The FDA is urging sponsors to submit better and more complete new drug applications, and to respond quicker to the Agency’s safety questions.

FDA Advisory Committee Recommeds Approval of New Rheumatoid Arthritis Therapy - Quick Pulse

Summary: The FDA's Arthritis Advisory Committee voted unanimously to recommend approval of Bristol-Myers Squibb's Orencia (abatacept), a first-in-class T-cell co-stimulation modulator, for the treatment of moderate-to-severe active rheumatoid arthritis. Panel members were concerned about an increased risk of serious infections and the potential risk of malignancy, but they were sufficiently impressed with the company's proposed risk management program to give Orencia a thumbs-up, saying the benefits outweigh the risks.