FDA grants orphan drug designation to serplulimab for small cell lung cancer
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The FDA granted orphan drug designation to serplulimab for treatment of small cell lung cancer.
Serplulimab (Hansizhuang, Shanghai Henlius Biotech) is a PD-1 inhibitor in development for first-line treatment of small cell lung cancer.
Small cell lung cancer — the most aggressive lung cancer subtype — accounts for an estimated 15% to 20% of lung cancer cases worldwide. It typically is associated with rapid disease progression, early metastasis and poor prognosis.
Standard treatment for limited-stage small cell lung cancer consists of surgery, chemotherapy and concurrent radiotherapy. Traditional chemotherapy agents typically do not provide much benefit, and most patients either relapse quickly or develop drug resistance.
Immune checkpoint inhibitors have been evaluated for patients with extensive-stage small cell lung cancer but multiple PD-1 monoclonal antibodies have failed to provide benefit, according to a Shanghai Henlius Biotech-issued press release.
The randomized phase 3 ASTRUM-005 trial evaluated chemotherapy with either serplulimab or placebo as first-line treatment for patients (n = 585; 31.5% white) with extensive-stage small cell lung cancer.
Results released in December 2021 showed the study met its primary endpoint of OS, demonstrating a 38% reduction in risk for death with the serplulimab regimen in the overall study population.
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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