Human Reovirus Formulation Receives FDA Orphan Drug Designation for Fallopian Tube Cancer
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for Oncolytics Biotech’s proprietary formulation of the human reovirus (Reolysin) for the treatment of fallopian tube cancer. The designation was granted on the basis of the company's December 2014 application for an Orphan Drug designation encompassing ovarian, fallopian tube, and primary peritoneal cancers, which are generally treated as one indication. The reovirus received Orphan Drug designation for ovarian cancer in February 2015.
“The FDA's recognition of ovarian and fallopian tube cancers as distinctly separate indications paves the way for a more targeted approach to the treatment of gynecologic cancers,” said Brad Thompson, PhD, President and CEO of Oncolytics.
Oncolytics has supported two sponsored clinical studies assessing the human reovirus in the treatment of cancers of the fallopian tube. The first was a phase I/II clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal, and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of the reovirus, which provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized phase II trial (GOG186H) of weekly paclitaxel vs weekly paclitaxel with the reovirus in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. The second trial completed enrollment in September 2014.
The incidence rate of fallopian tube cancers is estimated to be 0.37 per 100,000 women. Approximately 15,750 patients are affected with fallopian tube cancer at any time in the United States. The median survival of women in the United States with fallopian tube cancers is 58 months.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
