YM BIOSCIENCES GETS FAST-TRACK DESIGNATION FOR TESMILIFENE

YM BioSciences has announced that the 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.

Tesmilifene is a small molecule chemopotentiator currently undergoing a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer that has completed enrollment. The trial compares tesmilifene combined with epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and recurrent breast cancer.