Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has granted fast track designation to YM BioSciences' investigational anticancer drug, tesmilifene, for use in combination with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer.
Subscribe to our email newsletter
YM BioSciences received a letter from the FDA confirming the fast track designation, but the company said that it is seeking clarification from the FDA on certain aspects of the letter.
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.
Tesmilifene is a small molecule chemopotentiator currently undergoing a 700-patient pivotal phase III trial in metastatic and recurrent breast cancer. The trial compares tesmilifene combined with epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and recurrent breast cancer.
YM is also initiating a phase II trial in collaboration with Sanofi-Aventis combining tesmilifene with Taxotere for the treatment of metastatic and recurrent breast cancer.