This morning heralds the long awaited ODAC meeting for AstraZeneca’s oral SERD, camizestrant, for the treatment of HR+ HER2- breast cancer when given on biochemical relapse, as defined by the appearance of the ESR1 mutation.

All aboard! Which SERD train is racing ahead or being grounded?

While headline media reports usually focus on the 56% reduction in the risk of progression, characterising safety as “consistent with earlier findings,” or highlighting improvement in the patient reported outcomes (PROs), the actual regulatory tension is far more complex and centres on a number of complex issues.

After seeing a disconnect between clinical enthusiasm and FDA scepticism, I thought this would be a useful opportunity to offer a quick take on how this might go down later today by looking at some of the issues which have arisen…

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