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Some new news today FDA Fastract–Hope this helps
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FDA fast tracks Spectrum, Allergan cancer drug
Spectrum Pharma and Allergan say FDA gives fast track status to EOquin for bladder cancer
On Tuesday July 21, 2009, 9:30 am EDT
Buzz up! 0 Print.Companies:Allergan inc.Spectrum pharmaceuticals, inc.
NEW YORK (AP) — Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer.Related Quotes
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AGN 49.23 -0.68SPPI 6.36 +0.49
{“s” : “agn,sppi”,”k” : “c10,l10,p20,t10″,”o” : “”,”j” : “”} The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market.
The companies are enrolling patients in a late-stage clinical trial of the drug.
EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and Europe.
Phase III trials
Purpose
This is a multicenter, randomized, placebo-controlled, double-blind, study. Following TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® (Apaziquone) or matching placebo instilled within 6 hours of surgery. Patients will be seen for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report will be reviewed. If the histology of the patient’s tumor is Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence and progression. If the histology of the patient’s tumor is other than Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive further treatment in accordance with current treatment guidelines, following which the patient will be followed up cystoscopically every three months through year two for tumor recurrence and progression.The primary endpoint is to evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.
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2 Replies
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Me too! But I was happy to see some new developments in BC wars….I just ran across it by chance as I was doing dome stock research to try and get back some of my losses….I just hope it’s as good as it seems to be…and I hope you are too! I do hope this new treatment can help in the future BC Battles…Yosarian
What is a “free” gift? Aren’t all gifts free?
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They told me I was gullible and I believed them.The toilets at a local police station have been stolen. Police say they have nothing to go on.
— Ronnie Barker (from the Two Ronnies, 1972, BBC)PS…Thanks for all you do…
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Hi YO….good to have you back. I’d sure hate to be in that placebo half!!
Pat
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