Adventrx Pharmaceuticals, Inc. announced that it received a complete response letter from the US Food and Drug Administration (US FDA) regarding the company's New Drug Application (NDA) for Exelbine (vinorelbine injectable emulsion) for the treatment of Non-Small Cell Lung Cancer (NSCLC).
The FDA determined that it could not approve the Exelbine NDA in its present form. In particular, the complete response letter noted that, based on inspections at clinical sites, the authenticity of the drug products used in the pivotal bioequivalence trial (Study 530-01) could not be verified, which placed the results of the trial into question. The letter stated that the bioequivalence trial will need to be repeated to address this deficiency.
In addition, the FDA requested information regarding product quality, or CMC matters. All CMC information requests in the complete response letter were the subject of FDA inquiries from earlier in the review cycle, and the Company had submitted responses to each request prior to receipt of the complete response letter.
“We are disappointed with the FDA's determination and, next week, plan to request a type A meeting to discuss its response. Following that meeting, we will be in a better position to comment on the future of our Exelbine program. However, we believe the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA's concerns in this regard. We also will inquire whether FDA has comments to our previously submitted responses,” said Brian M Culley, chief executive officer of Adventrx.
“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. Our cash and equivalents of $ 40.7 million at July 31, plus cost savings from delaying or potentially discontinuing the Exelbine programme, will provide us the capital to continue to advance both of these programmes,” Culley added.
The company believes that FDA's concern over drug product authenticity stems from the procedures used to select testing and reserve samples in Study 530-01 and the availability of testing and reserve samples for inspection. The Company believes the procedures used to select testing and reserve samples in Study 530-01 were adequate to verify the authenticity of the drug products. Of note, Exelbine and the reference product come in different package presentations, require different preparation procedures and have different physical characteristics. Based on the different characteristics between the study drugs, the company believes it is unlikely that study sites would confuse the two study drugs or fail to recognize which drug was being administered to a patient.
Adventrx Pharmaceuticals is a specialty pharmaceutical company focused on developing proprietary product candidates.