Cancer drug trial halted after patient death: 3 things to know

Mackenzie Bean - Print  | 

The FDA placed a clinical hold on Advaxis' combination cancer drug study March 9 after a patient death occurred last month.

Here are three things to know.

1. The clinical trial was assessing the use of axalimogene filolisbac, Advaxis' experimental immunotherapy drug, in combination with AstraZeneca's cancer drug Imfinzi to treat HPV-associated cervical, head and neck cancers.

2. A cervical cancer patient participating in the trial developed respiratory failure and died Feb. 27, causing the FDA to halt the trial.

3. Advaxis paused enrollment and further dosing in the clinical trial. The drugmaker is working with AstraZeneca and the FDA to review the patient death.

"We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers," said Anthony Lombardo, interim CEO of Advaxis. "We are confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers."

More articles on supply chain:

Pfizer sells neurology drug to Biogen in nearly $600M deal: 4 things to know
4 latest FDA approval
FDA approves world's smallest heart valve for newborns

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.