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Patrick Forde: Interesting ODAC for future perioperative trial designs

Photo of Patrick Forde from facebook.com

Jul 27, 2024, 02:50

Patrick Forde: Interesting ODAC for future perioperative trial designs

Patrick Forde, Professor at the Johns Hopkins University, shared a post on X by FDA Oncology, adding:

“Interesting ODAC (Oncologic Drugs Advisory Committee), future perioperative trial designs should consider contribution of phases but AEGEAN (neoadjuvant chemo-durva followed by adjuvant durva) looks like it will be approved. Would have been difficult not to do so post approval of KN671 with a very similar design.”

Quoting FDA Oncology’s post:

“Oncologic Drugs Advisory Committee votes 11 to 0 in favor of FDA requiring that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within trial assessment of contribution of treatment phase.”

Screen capture of a voting result with date and time displayed as "7/25/2024, 1:31:57 PM." The table shows names under "Yes" including Ashley Rosko, MD, Azam Ghafoor, MD, and others, totaling 11 votes. The "No" and "Abstain" categories record 0 votes.

Link to video.
Sources: Patrick Forde/X and FDA Oncology/X

AEGEAN Aegean Trial cancer Durvalumab FDA Oncology Johns Hopkins University KN671 non small cell lung cancer NSCLC ODAC OncoDaily Oncologic Drugs Advisory Committee Oncology Patrick Forde

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