FoundationOne CDx (FICDx)
FDA premarket approval P170019/S033 · decided 2022-03-16
Approval details
- PMA number
- P170019
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (FICDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2021-12-23
- Decision date
- 2022-03-16
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for FoundationOne CDx (FICDx) label expansion to obtain companion diagnostic group labeling claim for non-small cell lung cancer patients harboring EGFR exon 19 deletions or EGFR exon 21 L858R mutations for treatment with any one of the FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI).
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