TRACON Pharmaceuticals Inc (NASDAQ:TCON) announced that its undifferentiated pleomorphic sarcoma (UPS) drug envafolimab has been granted fast track designation by the US Food and Drug Administration.
The designation covers the development of envafolimab for patients with locally advanced, unresectable or metastatic UPS and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.
“We applied for fast track designation based on activity observed in the ENVASARC Phase 2 pivotal trial and are pleased to receive this notification from the FDA,” CEO Charles Theuer said in a statement.
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“Soft tissue sarcoma is a disease in need of new treatments and we expect to provide data through the ENVASARC pivotal trial showing superior efficacy and safety of envafolimab compared to currently approved therapy for refractory soft tissue sarcoma,” he added. “Accrual in the pivotal ENVASARC trial remains robust and we expect to report an independent data monitoring committee interim safety review and interim efficacy review in the fourth quarter.”
FDA fast track designation comes with important benefits, including the potential eligibility for priority review of a Biologics License Application, the company said.
San Diego-based TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies.
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