health
AstraZeneca stock falls after FDA panel votes against new cancer drug
The advisory panel wasn't convinced that a clinical trial proved that early switching to camizestrant improved long-term survival rates.
TL;DR
- An FDA advisory panel voted 6-3 against approving AstraZeneca's experimental cancer drug, camizestrant.
- The panel cited concerns about the trial design and whether it proved improved long-term survival rates compared to standard treatments.
- The vote was based on Phase 3 results of the SERENA-6 trial, which showed a reduction in disease progression or death risk.
- Panel members suggested that the data did not conclusively support an early change in therapy.
- The drug's safety and toxicity were not significant concerns for the panel.
- AstraZeneca expressed continued belief in the drug and will work with the FDA.
- Analysts noted that the SERENA-6 trial is a small part of AstraZeneca's overall sales goals.
- AstraZeneca shares fell 2% following the vote.