The U.S. Food and Drug Administration has granted fast track status to Reolysin for treating metastatic breast cancer, according to its developer, Oncolytics Biotech.
Fast track accelerates the review of therapies for serious conditions with unmet medical needs. It will enhance the dialogue between the FDA and Oncolytics on the company’s drug development plans, information required for final regulatory approval, and clinical trial designs.
“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,” Dr. Matt Coffey, president and CEO of Oncolytics Biotech, said in a press release. “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.”
Reolysin is a proprietary formulation of the human reovirus that replicates inside cancer cells, leading to their death. By releasing specific cancer proteins when a cancer cell dies, the virus also promotes strong immune responses against the remaining cancer cells.
Information presented in April 2017 at the American Association of Cancer Research annual meeting, showed that women with metastatic breast cancer who were treated with Reolysin and Taxol (paclitaxel) lived considerably longer than those receiving Taxol alone.
The open-label Phase 2 IND 213 trial from which the information was drawn assessed Reolysin’s safety and effectiveness in 74 metastatic breast cancer patients. The Canadian Cancer Trials Group designed and conducted the study.
While the study did not meet its primary disease-progression-free survival objective, researchers saw an unexpected seven-month improvement in overall survival — from 10.4 months to 17.4 months.
In the 61 patients with P53 mutations the results were even more striking. Those receiving Reolysin and Taxol lived a median of 20.9 months, more than double the 10.4 months of patients treated with Taxol alone.