ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

To access this subscriber-only content please log in or subscribe.

If your institution has a site license, log in with IP-login or register for a sponsored account.*
*Not all site licenses are enrolled in sponsored accounts.

Login Subscribe
Jacquelyn Cobb
Associate Editor
Table of Contents

YOU MAY BE INTERESTED IN

Data from the phase III ASCENT-03 study demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival for Trodelvy (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors. 
Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer who are not eligible for or declined cisplatin-based chemotherapy, according to phase III KEYNOTE-905/EV-303 trial data. 
Jacquelyn Cobb
Associate Editor

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login