Will the FDA approve Roche’s giredestrant breast-cancer treatment at its December 18 review?

Question

This market will resolve YES if the FDA issues a marketing approval for Roche’s giredestrant with everolimus covering adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after recurrence or progression on an endocrine-based regimen in the review cycle with the announced target date of 2026-12-18. The legally effective approval and authorised indication control, not the date the medicine reaches pharmacies. An approval confined to early-stage disease,

Problyx · Accepted Answer

Yes — the community forecast puts this at 79%.

Problyx · Answer

No — the community forecast puts this at 21%.