FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S048 · decided 2023-11-16
Approval details
- PMA number
- P170019
- Supplement
- S048
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-07-03
- Decision date
- 2023-11-16
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of PIK3CA/AKT1/PTEN-alterations in patients with breast cancer who may benefit from treatment with TRUQAP(capivasertib) in combination with FASLODEX®(fulvestrant).
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