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YM BioSciences drug tesmilifene put on fast track by FDA
By Elaine Rigoli
Tampa, Fla., Feb. 13 - YM BioSciences Inc. announced Monday that the U.S. Food and Drug Administration has given tesmilifene for treatment of metastatic/recurrent breast cancer fast-track status.
However, YM added that it "is seeking clarification from the FDA on certain aspects of the letter."
Tesmilifene, the company's lead drug, is a small molecule used in conjunction with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer, according to a company news release.
As part of its 700-patient phase 3 trial, YM BioSciences is trying to determine whether tesmilifene, when used with other chemotherapy treatments, improves the effectiveness of common chemotherapies and extends survival rates. The company is comparing the effects of epirubicin/cyclophosphamide combined with tesmilifene, against epirubicin/cyclophosphamide used alone in women with rapidly progressing metastatic and recurrent breast cancer.
The aim of the FDA's fast-track program is to speed up the review of new therapies and accelerate the marketing of new drugs. Developers with fast-track status collaborate directly with the FDA about trial design. Portions of the new drug application may be accepted prior to the completion of the final registration package and most fast-track drugs receive priority review upon filing a New Drug Application.
YM BioSciences is a Mississauga, Ont.-based cancer product development company. YM is also currently initiating a phase 2 trial in collaboration with Sanofi-Aventis combining tesmilifene with Taxotere for the treatment of metastatic and recurrent breast cancer.
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