FDA's Oncologic Drugs Advisory Committee to Review AstraZeneca's Cancer Drugs in First Meeting in 9 Months
The FDA's Oncologic Drugs Advisory Committee (ODAC) will meet on April 30, 2026, marking the first cancer advisory panel in over nine months since July 2025.124
Morning session:
Review of AstraZeneca's new drug application (NDA 220359) for camizestrant, an oral SERD, combined with CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer with ESR1 mutations in first-line therapy, supported by Phase 3 SERENA-6 data showing 56% reduction in progression risk.146
Afternoon session:
Review of supplemental NDA (sNDA 218197/S-004) for Truqap (capivasertib), an AKT inhibitor, to expand to metastatic hormone-sensitive prostate cancer, backed by Phase 3 CAPItello-281 trial data improving progression-free survival.148
The meeting is announced in the Federal Register and FDA documents, amid discussions on advisory panel transparency and balance.237
Sources:
1. https://www.biospace.com/fda/two-astrazeneca-drugs-to-be-scrutinized-in-first-fda-cancer-advisory-panel-in-9-months
2. https://www.center4research.org/biospace-first-fda-cancer-advisory-committee-in-2026/
3. https://www.thebiointel.com/article/fda-advisory-panel-astrazeneca-cancer-drugs-review-nine-months
4. https://www.fda.gov/media/192151/download
6. https://www.fda.gov/media/192156/download
7. https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-30-2026-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04302026