On August 11, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for onapristone extended release (ONA-XR), for the treatment of patients with progesterone receptor positive (PR+) ovarian cancer (Press release, Context Therapeutics, AUG 11, 2020, View Source [SID1234563433]).
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"We are very encouraged by the FDA’s decision to grant us Fast Track Designation for our lead program ONA-XR, which has shown very encouraging activity and tolerability in our ongoing Phase 2 study in advanced PR+ ovarian cancers. We believe this recognition underscores the high unmet medical need for a treatment for patients with PR+ ovarian cancer," said Martin Lehr, Chief Executive Officer of ContextTherapeutics. "With this designation in hand, we plan to be able to quickly advance through the administrative steps of ONA-XR’s development and bring forth a therapy for these patients as soon as possible."
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a New Drug Application (NDA).
About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trial in progesterone receptor positive ovarian cancer. Additional Phase 2 clinical trials in breast and endometrial cancers will initiate in 2020. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.