FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S049 · decided 2023-11-02
Approval details
- PMA number
- P170019
- Supplement
- S049
- Supplement type
- Special (Immediate 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
- 2023-10-03
- Decision date
- 2023-11-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for (1) removal of the Truseltiq® (infigratinib) companion diagnostic indication for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement and (2) removal of the Rubraca® (rucaparib) complementary diagnostic indication for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal
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