Overview
- AstraZeneca’s oncology filings drew mixed verdicts, with the FDA’s cancer advisory panel on Thursday voting 6–3 against camizestrant for HR‑positive, HER2‑negative breast cancer and 7–1 in favor of Truqap for a form of metastatic prostate cancer.
- Panelists said the SERENA‑6 strategy—switching to camizestrant when an ESR1 mutation appears before tumors show up on scans—did not prove better long‑term outcomes, and they flagged immature overall survival and second‑progression data at the interim look, while noting safety was not a key concern.
- SERENA‑6 reported a 56% drop in the risk of progression or death and a median progression‑free survival of 16 months versus 9.2 months on standard care, and a later analysis showed a benefit on time to second progression with an overall survival trend that reviewers still considered too early to confirm.
- For Truqap in PTEN‑deficient metastatic hormone‑sensitive prostate cancer, evidence from the CAPItello‑281 study showed a 19% reduction in the risk of radiographic progression or death and median progression‑free survival of 33.2 months versus 25.7 months, with more severe side effects but a known safety profile.
- AstraZeneca shares slipped about 1% to 2% Friday morning as the company said it remains confident and will keep working with the FDA, whose final decisions are not bound by the votes, while analysts warned the negative camizestrant view adds regulatory overhang and likely preserves current first‑line practice for now.