Transgene has announced that the US Food and Drug Administration (FDA) has granted fast-track development designation to its immunotherapy product TG4010 as a first-line treatment for advanced non-small cell lung cancer (NSCLC).
The FDA's fast-track programme is designed to facilitate and boost the development of new treatments such as TG4010, which has shown good results as a first-line treatment in combination with chemotherapy to improve survival in patients with advanced MUC1-positive NSCLC and normal levels of activated natural killer cells.
Fast-track status follows earlier clearance from the FDA to proceed to Phase III trials based on positive clinical data from a controlled Phase IIb trial, which met its primary end point of progression-free survival at six months and also confirmed a six-month increase in median survival after 24 months.
Transgene CEO Philippe Archinard said that the firm is actively preparing the next development steps for the product.
"Discussions for the partnering of TG4010 have progressed and we hope to reach a collaborative agreement around the end of 2009," Archinard said.
TG4010 (MVA-MUC1-IL2) uses the modified vaccinia Ankara virus vector, a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate innate and adaptive immune responses to antigens.