Oncolytics Biotech announces FDA fast track designation for Reolysin in metastatic breast cancer

Oncolytics Biotech

8 May 2017 - Oncolytics Biotech announced today that the United States FDA has granted fast track designation for Reolysin, the company's proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer.

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.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Submission , Fast track