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Biotech / Medical : Depotech(depo) -- Ignore unavailable to you. Want to Upgrade?

To: Czechsinthemail who wrote (742)	3/3/1998 8:42:00 AM
From: BD	Respond to of 887

John, Thanks again for the insight, I have been waiting for more confirmation on this as well. Any word on FDA meetings?

To: Czechsinthemail who wrote (742)	3/3/1998 4:57:00 PM
From: Dr. John M. de Castro	Read Replies (2) \| Respond to of 887

The aracnoiditis data were presented by DEPO at a meeting. But, IMHO these are not biased as these are the actual numbers and not interpretations. In addition, the data were calculated on an Intent-to-Treat basis, not in DEPO's less conservative evaluable patient format. So, these data are in the form that ODAC required. In order to understand the frequency of Dexamethasone treatment it is necessary to understand the protocol. DepoCyt was administered once every other week, while the Methotrexate group received injections twice a week. Dexamethasone was administered for 5 days with each injection. Hence, the DepoCyt group had an injection, followed by 5 days of DEX, followed by 9 days without DEX, and then another injection. The methotrexate group had biweekly injections and had to have been on DEX all of the time. So, if DEX has harmful side effects then they should have been worse in the Methotrexate group than in the DepoCyt group. Although DEX has some side effects, I seriously doubt that they would be noticeable in such sick patients as these. They are being given highly toxic chemotherapeutic agents. The effects of DEX pale in comparison. As you can see in the table I put in my prior post, arachnoditis is just as likely with Methotrexate as with DepoCyt and Dexamethasone has comparable effectiveness in ameliorating the symptoms with both. So, DEX is called for in either case. I'm not sure, but I believe that DEPO is proposing that DEX administration be indicated on the label that they are requesting from the FDA for DepoCyt. I don't believe that the primary hurdle for DEPO is to prove the efficacy for DepoCyt. It is unquestionably effective. The problem arose at ODAC because ODAC suddenly switched criteria on DEPO. They required DepoCyt to show superior efficacy to Methotrexate. DEPO's data were unequivocal that DepoCyt worked. It just wasn't unequivocal that DepoCyt worked better than Methotrexate. IMHO eventually the comparability of effectiveness, given the less frequent administration, will win out and DepoCyt will be approved. John de C