Oncolytics Biotech, a biotechnology company, announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for Reolysin, the company’s proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer.
“Fast Track designation represents an important step for our clinical development plan, which is squarely focused on a registration pathway in metastatic breast cancer and advancing Reolysin to regulatory review as quickly as possible,” said Dr. Matt Coffey, president and chief executive officer of Oncolytics Biotech. “Our goal is to conduct an End-of-phase 2 meeting with the FDA as soon as is practical and obtain scientific guidance. We are eager to leverage this designation and use the opportunity for more frequent dialogue with the FDA, as well as the potential for an expedited review process, to support the future development of Reolysin.”
In April 2017, data from an open-label, randomized, phase 2 study assessing the therapeutic combination of intravenously-administered Reolysin given in combination with the chemotherapy agent paclitaxel versus paclitaxel alone, in patients with advanced or metastatic breast cancer (IND 213) was presented at the American Association of Cancer Research Annual Meeting. The combined treatment demonstrated a statistically significant increase in median overall survival. Based on Oncolytics’ evolving understanding of Reolysin’s mechanism of action, along with the positive overall survival data generated to date, the Company is pursuing metastatic breast cancer as its primary focus for late-stage clinical testing.
The FDA’s Fast Track process is designed to facilitate the development, and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Fast Track designation supports more frequent dialogue with the FDA on a company’s drug development plan, data requirements and clinical trial design. It also, in certain situations, enables the FDA to take action on a new drug or biologics license application more rapidly than under the standard review process.
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