Transgene Receives FDA Fast Track Status for TG4010 for Treatment of Non-Small Cell Lung Cancer
Transgene announced that the U.S. food & Drug Administration (FDA) has granted Fast Track development designation to its immunotherapy product TG4010 (MVA-MUC1-IL2) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy.
The FDA determined that TG4010 meets the criteria for the Fast Track designation, facilitating the development of TG4010 for the first-line treatment in combination with chemotherapy to improve survival in patients with advanced MUC1-positive NSCLC and normal levels of activated Natural Killer (NK) cells. The granting of Fast Track status follows the FDA’s earlier clearance to proceed to phase III trial based on positive clinical data from a controlled phase IIb trial of TG4010 in patients with advanced NSCLC.
The phase IIb trial was a randomized, open label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The trial completed the enrolment of 148 patients at the end of May 2007 in 27 centres located in France, Poland, Germany, and Hungary. The trial met its primary end point with a progression-free survival at 6 months of 45 % in the experimental arm.
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