Table 1.
FDA-approved FoundationOne CDx assays until 22 March 2021.
| Cancer type | Companion diagnostic | Associated biomarker | FDA-approved drug |
|---|---|---|---|
| Non-small cell lung cancer | FoundationOne CDx | EGFR exon 19 deletions and EGFR exon 21 L858R alterations | Gilotrif® (afatinib), Iressa® (gefitinib), Tagrisso® (osimertinib), or Tarceva® (erlotinib) |
| EGFR exon 20 T790M alterations | Tagrisso® (osimertinib) | ||
| ALK rearrangements | Alecensa® (alectinib), Xalkori® (crizotinib), or Zykadia® (ceritinib) | ||
| BRAF V600E | Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) | ||
| MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping | TabrectaTM (capmatinib) | ||
| FoundationOne liquid CDx | ALK rearrangements | Alecensa® (alectinib) | |
| EGFR exon 19 deletions and EGFR exon 21 L858R substitution | Iressa® (gefitinib), Tagrisso® (osimertinib), or Tarceva® (erlotinib) | ||
| Melanoma | FoundationOne CDx | BRAF V600E | Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) |
| BRAF V600E or V600K | Mekinist® (trametinib) or Cotellic® (cobimetinib), in combination with Zelboraf® (vemurafenib) | ||
| Breast cancer | FoundationOne CDx | ERBB2 (HER2) amplification | Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab) |
| PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations | Piqray® (alpelisib) | ||
| FoundationOne liquid CDx | PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, and H1047Y | Piqray® (alpelisib) | |
| Colorectal cancer | FoundationOne CDx | KRAS wild-type (absence of mutations in codons 12 and 13) | Erbitux® (cetuximab) |
| KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) | Vectibix® (panitumumab) | ||
| Ovarian cancer | FoundationOne CDx | BRCA1/2 alterations | Lynparza® (olaparib) or Rubraca® (rucaparib) |
| FoundationOne Liquid CDx | BRCA1, BRCA2 alterations | Rubraca® (rucaparib) | |
| Cholamgiosarcoma | FoundationOne CDx | FGFR2 fusions and select rearrangements | Pemazyre® (pemigatinib) or Truseltiq™ (infigratinib) |
| Colon cancer | FoundationOne CDx | Homologous Recombination Repair (HRR) gene (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and RAD54L) alterations | Lynparza® (olaparib) |
| Prostate cancer | FoundationOne Liquid CDx | BRCA1, BRCA2, ATM alterations | Lynparza® (olaparib) |
| BRCA1, BRCA2 alterations | Rubraca® (rucaparib) |