Will the FDA approve camizestrant for advanced breast cancer?
1.0 Pkt. (24h)Health & MedicineOne-Off2Mon
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14. Mai 26, 2:001. Okt. 26, 3:59
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If the FDA approves camizestrant for HR+/HER2- advanced breast cancer with ESR1 mutation for marketing before Jun 1, 2026, then the market resolves to Yes.
- An approval is defined as:
- For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application
- The following constitute approvals that trigger the Payout Criterion:
- Standard approval (traditional approval based on clinical benefit) Accelerated approval (based on surrogate endpoints) Approval with Risk Evaluation and Mitigation Strategy (REMS) Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
- The following do NOT constitute approvals: