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eric · 02-13-2006, 06:09 PM

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http://today.reuters.com/business/ne...5&imageid=&cap=

YM BioSciences breast cancer drug wins fast review
Monday 13 February 2006, 9:15am EST
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CHICAGO, Feb 13 (Reuters) - YM BioSciences Inc. (YM.TO: Quote, Profile, Research), a Canadian biopharmaceutical company, on Monday said U.S. regulators agreed to a "fast track" review of its lead drug, tesmilifene, for the treatment of breast cancer.

The drug is used in combination with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer.

The company said it is seeking clarification from the U.S. Food and Drug Administration on certain aspects of the letter it received confirming the fast-track designation.

Tesmilifene is currently in a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. The fast-track program expedites the review of new therapeutics intended to treat serious or life-threatening diseases and address unmet medical needs.

02-13-2006, 06:09 PM	#1
eric Senior Member Join Date: Sep 2005 Posts: 589	Tesmilifene wins fast track review if ((!document.images && navigator.userAgent.indexOf("Mozilla/2.") >= 0) \|\| navigator.userAgent.indexOf("WebTV") >= 0) { document.write('');document.write('');} http://today.reuters.com/business/ne...5&imageid=&cap= YM BioSciences breast cancer drug wins fast review Monday 13 February 2006, 9:15am EST Printer Friendly \| Email Article \| Reprints \| RSS CHICAGO, Feb 13 (Reuters) - YM BioSciences Inc. (YM.TO: Quote, Profile, Research), a Canadian biopharmaceutical company, on Monday said U.S. regulators agreed to a "fast track" review of its lead drug, tesmilifene, for the treatment of breast cancer. The drug is used in combination with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer. The company said it is seeking clarification from the U.S. Food and Drug Administration on certain aspects of the letter it received confirming the fast-track designation. Tesmilifene is currently in a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer. The fast-track program expedites the review of new therapeutics intended to treat serious or life-threatening diseases and address unmet medical needs.