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FDA grants orphan drug designation to TRC105 for soft tissue sarcoma
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The FDA granted orphan drug designation to TRC105 for the treatment of patients with soft tissue sarcoma.
TRC105 (TRACON Pharmaceuticals) is a novel antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis.
The agent is being evaluated in several phase 2 trials for use in combination with VEGF inhibitors for treatment of patients with solid tumors.
“Orphan drug designation for TRC105 underscores the high level of unmet medical need in patients with soft tissue sarcomas and validates our commitment to developing TRC105 in a variety of orphan drug indications,” Charles Theuer, MD, PhD, president and CEO of TRACON, said in a company-issued press release. “We are highly encouraged by the clinical data reported to date from the Phase 1b/2 trial of TRC105 in sarcoma patients, especially in patients with angiosarcoma. We look forward to the availability of complete results from the Phase 2 portion of the sarcoma trial and initiating a pivotal phase 3 trial in patients with angiosarcoma in 2016.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — seven years of market exclusivity.