Please login to the form below

Not currently logged in

FDA rejects Adventrx’s lung cancer drug Exelbine

Adventrx receives rejection from the FDA for its new non-small cell lung cancer drug, Exelbine, over authenticity issues

The US Food and Drug Administration (FDA) has rejected Adventrx Pharmaceuticals' New Drug Application (NDA) for Exelbine, a drug for the treatment of non-small cell lung cancer. Exelbine is a reformulated version of Pierre Fabre Pharmaceuticals' Navelbine.

This rejection from the FDA has caused shares in Adventrx Pharmaceuticals to plunge as much as 61 per cent.

In the complete response letter that Adventrx received, the FDA decided that it could not approve the Exelbine NDA in its present form as the “authenticity of the drug products used in the pivotal bioequivalence trial could not be verified, which placed the results of the trial into question”. It stated that this trial would have to be repeated in order to address the problem.

Adventrx is planning to request a meeting with the FDA to discuss the FDA's response to the application which contradicts the views of Adventrx, which believes that the authenticity of the drug products are verifiable.

11th August 2011


Featured jobs

Subscribe to our email news alerts


Add my company
Anthill Agency

Anthill is a specialist digital agency and a strategic partner for life science companies....

Latest intelligence

Why patient education isn’t simple
Patient education is often understood to be the imparting of knowledge from the healthcare professional (HCP) to the patient and/or their caregiver. However, in most cases, the imparting of knowledge...
Beyond the event
Anthill Agency and Actando partnership to Transform Pharma's Digital Skills
Anthill Agency, a leading life sciences digital agency, today announced the launch of the Anthill Academy™ and partnership with Actando's PharmAcademy....