TRACON Pharmaceuticals said the U.S. Food and Drug Administration has granted orphan drug designation to envafolimab, a single-domain antibody against PD-L1, for the treatment of patients with soft tissue sarcoma.
The biopharmaceutical company said the designation follows submission of an amended application that included Phase 1 clinical trial data from sarcoma patients treated with single agent envafolimab. Clinical trial data were submitted in response to an FDA request to provide data using envafolimab to treat patients with soft tissue sarcoma that showed a therapeutic effect.
The orphan drug designation submission for envafolimab in sarcoma included clinical data demonstrating confirmed objective partial responses with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma who received single agent envafolimab in Phase 1 clinical trials. Patients with undifferentiated pleomorphic sarcoma or myxofibrosarcoma were not treated as part of Phase 1 trials.
Orphan drug designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the U.S. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.
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