Trends-in-Medicine
	Lynne Peterson, Senior Writer Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter. Copyright©  2004 No articles may be reproduced without written permission of the publisher. Return Home
					May 2004 Issues FDA Oncologic Drugs Advisory Committee (ODAC) Meeting on Clinical Trial Endpoints in Colorectal Cancer (CRC) Summary: The FDA has been working for more than a year on updating clinical trial endpoint requirements in a variety of different cancer trials. The Oncologic Drugs Advisory Committee (ODAC) made several recommendations to the FDA on what new endpoints should be adopted for colorectal trials. Association for Research in Vision and Ophthalmology (ARVO) Summary: Retinal specialists are expecting to use the new AMD therapies in combination, but there is no consensus on which are the best combinations. Concern over the pooled data and carcinogenicity of Eyetech’s Macugen for AMD appears to be lessening. In glaucoma, the same marketing wars that have raged over Travatan-Xalatan- Lumigan are likely to occur when combination products (prostaglandin+beta blocker) are approved. LASIK procedure volume has picked up, but the 2004 outlook is still extremely dependent on the economy. Use of custom ablation is continuing to increase. Refractec’s CK appears to be catching on. Products to watch: (1) Neuroprotectives, particularly Allergan’s memantine and Posurdex and Teva’s Copaxone; (2) Allergan’s preservative-free formulation of triamcinolone; (3) Alcon’s ReSTOR accommodating IOL and AMO’s ReZoom lens; (4) Novartis’ pimecrolimus drops for dry eye; and (5) rheophoresis. FDA Oncologic Drugs Advisory Committee (ODAC) Rejects Genta's Genasense and Allos Therapeutics Summary: Both Genta’s Genasense and Allos’s RSR- 13 missed their primary endpoints. Genta tried to get approval on a secondary endpoint, and Allos wanted approval based on a subset analysis that was not prespecified. The ODAC panel rejected both arguments, sending three strong messages to industry: (1) Don’t expect approval of a drug that misses its primary endpoint, (2) slicing and dicing data won’t turn a sow’s ear into a silk purse or a failed drug into an approvable one, and (3) ODAC can make tough decisions even in the face of Congressional and patient pressure. FDA Oncologic Drugs Advisory Committee (ODAC) Meeting on the Safety of Erythropoietin in Oncology - Quick Pulse Summary: The FDA's Oncologic Drugs Advisory Committee (ODAC) met to help the FDA figure out how to structure clinical trials to prove whether all erythropoietins (EPOs) affect mortality (decrease survival) in cancer patients. The FDA believes these trials are necessary after European reports of a potential mortality decrement with two European products -- Johnson & Johnson's Eprex and Roche's NeoRecormon. The U.S. studies will look at Amgen's Aranesp and Johnson & Johnson's Procrit.
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