YM BioSciences receives FDA fast track designation for tesmilifene in advanced breast cancer
YM BioSciences Inc. announced that the U.S. food and Drug Administration (FDA) has designated as a fast track product the Company's lead drug, tesmilifene, for use in combination with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer. While the Company is seeking clarification from the FDA on certain aspects of the letter, the letter confirms that YM BioSciences' lead drug, tesmilifene, meets the criteria for fast track designation for treatment of metastatic/recurrent breast cancer.
The Fast Track program facilitates the development and expedites the review of new therapeutics that are intended to treat serious or life threatening diseases and demonstrate the potential to address unmet medical needs. The FDA will also provide input into product development plans and may accept portions of the marketing application prior to the completion of the final registration package. Most drugs that are designated for the Fast Track Program are given priority review once a New Drug Application (NDA) is filed. Tesmilifene is a small molecule chemopotentiator currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer that has completed enrolment. The trial compares tesmilifene combined with epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and recurrent breast cancer.
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