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FDA grants fast track designation to Reolysin for metastatic breast cancer
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The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.
Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.
An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.
Patients assigned the combination achieved significantly longer median OS than those assigned paclitaxel alone.
“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,” Matt Coffey, PhD, MBA, president and CEO of Oncolytics Biotech, said in the press release.
The company plans to conduct an end-of-phase 2 meeting with the FDA to obtain scientific guidance, Coffey said.
“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,” he said.
Pelareorep is under investigation for treatment of multiple cancer types.