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news.The US Food and Drug Administration (FDA) has issued complete response letter (CRL) to US based Adventrx Pharmaceuticals' new drug application (NDA) for Exelbine (vinorelbine injectable emulsion) as a treatment for non-small cell lung cancer.
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In its CRL, the FDA has rejected to approve the drug in its present form and has requested information related to the product quality or CMC matters.
Additionally, the FDA has questioned on the authenticity of the drug used in the pivotal bioequivalence trial (Study 530-01), following inspections conducted by the agency at clinical sites.
The letter stated that the bioequivalence trial will need to be repeated to address this deficiency.
Adventrx CEO Brian Culley said they believe the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA’s concerns in this regard.
"In the meantime, our resources and focus are on ANX-188 and ANX-514, which we believe are the long-term value drivers for our company," Culley said.