FDA grants orphan drug designation to toripalimab for esophageal cancer
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The FDA granted orphan drug designation to toripalimab for the treatment of esophageal cancer.
Toripalimab (Coherus/Junshi Biosciences) is an anti-PD-1 monoclonal antibody.
Clinical trials have been conducted or are underway to assess the agent’s efficacy and safety for a variety of tumor types, including esophageal, lung, nasopharynx, stomach, breast, bladder, liver, kidney and skin cancers.
The randomized phase 3 JUPITER-06 trial evaluated the addition of toripalimab to chemotherapy as first-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma.
The study met its co-primary endpoints, demonstrating statistically significant improvements in PFS and OS with the combination vs. chemotherapy alone.
Coherus and Junshi Biosciences intend to submit a biologics license application to the FDA next year for toripalimab in combination with platinum-based chemotherapy for first-line treatment of advanced or metastatic esophageal squamous cell carcinoma.
The FDA previously granted priority review to a biologics license application seeking approval of toripalimab for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma. The agency is expected to make a decision by April 2022.
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 — 7 years of market exclusivity.
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