The US Food and Drug Administration (FDA) has designated as a fast track product YM Biosciences' lead drug, tesmilifene, for use in combination with an anthracycline chemotherapeutic for the treatment of women with advanced breast cancer.

The FDA will also provide input into the product development plans of the company and may accept portions of the marketing application prior to the completion of the final registration package, states the company release.

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.

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. Separately, YM has licensed tesmilifene to the Shin Poong Pharmaceutical Company of Seoul, South Korea, under which Shin Poong plans to expand the development program into gastric cancer.

YM BioSciences Inc. is a cancer product development company. In addition to tesmilifene, YM is developing nimotuzumab, an anti-EGFr humanised monoclonal antibody, in a number of indications.