Oncolytics Biotech’s proprietary immuno-oncology viral agent for metastatic breast cancer has received a fast track designation from the United States Food and Drug Administration (FDA).
The company hopes the designation will bring them closer to getting further guidance from the FDA regarding their Reolysin treatment. The company is entering into late-stage clinical testing for 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 for Cancer Research Annual Meeting.
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.
In certain situations, the designation enables the FDA to take action on a new drug or biologics license application more rapidly than under the standard review process.
“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 CEO 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.”
The combined treatment of Reolysin and the chemotherapy agent paclitaxel demonstrated a statistically significant increase in median overall survival, according to Oncolytics. The company is pursuing metastatic breast cancer as its primary focus for late-stage clinical testing.