US regulator declines marketing application for Lung Cancer Drug, Exelbine

The US Food and Drug Administration snubbed Adventrx Pharmaceuticals’ application seeking an approval of Exelbine (vinorelbine) causing the company’s shares to slump as low as 61%. The drug, which is a reformulated version of Navelbin by Pierre Fabre Pharmaceuticals, is used for treating non-small-cell lung cancer.

In its response letter, the FDA stated, “the authenticity of the drug products used in the pivotal bioequivalence trial could not be verified,” placing the results in doubt. CEO Brian M. Culley commented, “We are disappointed with the FDA’s determination and…believe the authenticity of the drug products…is verifiable.” The US regulator not only asked the company to repeat the bioequivalence study but also sought more information regarding the quality of the product.
Subsequent to the submission of the marketing application for Exelbine last year in November, Adventrx is said to appeal for a meeting with the FDA to discuss the complete response letter. Culley said, “Following that meeting, we will be in a better position to comment on the future of our Exelbine program.”