Commercializationv1 · 10.13
Changing treatment before scans show progression: a new relationship between breast cancer drugs and blood tests ↗
What benefit comes from detecting a resistance mutation and switching treatment before radiographic progression?
European certification was added for Guardant360 CDx. Earlier switching prolonged PFS in selected SERENA-6 patients, while SERENA-4 under different conditions missed its primary endpoint. FDA requires confirmation comparing early switching with switching at progression.
- PFS benefit in selected patientsRecorded
- Compare early and progression-time switchingUnverified
- Long-term benefit and uptakeUnverified
New question opened
Linked European CDx certification, SERENA-6, SERENA-4 and FDA confirmation requirements through the question of treatment timing.
NEXT CHECK
Comparison of early and post-progression use of the same drug, longer-term survival and uptake in the indicated population.