AstraZeneca: meeting with an FDA advisory committee

(CercleFinance.com) - On Friday, AstraZeneca reported on yesterday's meeting with an FDA advisory committee concerning its application to market its Imfinzi immunotherapy for the treatment of operable non-small cell lung cancer.


According to AstraZeneca, the FDA's Oncologic Drugs Advisory Committee (ODAC) noted that the drug had met its primary endpoint of event-free survival in its Phase III clinical trial.

AstraZeneca said the meeting highlighted Imfinzi's potential in the treatment of operable non-small cell lung cancer.

The committee recognized that it is possible to address this urgent unmet need (...) before and after surgery, which could significantly increase the length of time patients live without disease progression or recurrence during this phase of curative intent", said Prof. John Heymach of the University of California, Berkeley. John Heymach, from the University of Texas, who participated in the clinical trials.

The FDA agreed to review Imfinzi's registration dossier in this indication in September 2023.

The ODAC is a committee that provides the FDA with independent expert recommendations. While the FDA generally heeds its advice, it is not obliged to align itself with the committee's conclusions.

On the London Stock Exchange, AstraZeneca shares gained 1.2% on Friday morning, erasing the previous day's losses due to the chilly reception given to its quarterly results.

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