FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S030 · decided 2022-01-19
Approval details
- PMA number
- P170019
- Supplement
- S030
- Supplement type
- Normal 180 Day 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
- 2021-07-01
- Decision date
- 2022-01-19
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval to expand the intended use of FoundationOne CDx (F1CDx) to expand the intended use of FoundationOne CDx (F1CDx) to include a companion diagnostic indication for identifying patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, who may benefit from treatment with atezolizumab (Tecentriq) in combination with cobimetinib and vemurafenib.
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