Biomarkers predictive of efficacy identified in the review of European Medicines Agency licensing
| Biomarker | Indication | Drug |
|---|---|---|
| ALK gene rearrangement | Carcinoma, non-small-cell lung | Crizotinib (Xalkori) |
| BRAF V600 mutation | Melanoma | Vemurafenib (Zelboraf) |
| CCR5 tropism | HIV infections | Maraviroc (Celsentri) |
| CD-33 expression* | Leukaemia, myeloid, acute | Gemtuzumab ozogamicin (Mylotarg)† |
| EGFR expression | Colorectal neoplasms | Cetuximab (Erbitux) |
| EGFR expression | Carcinoma, non-small-cell lung | Erlotinib (Tarceva) |
| EGFR mutation | Carcinoma, non-small-cell lung | Erlotinib (Tarceva) |
| EGFR mutation | Carcinoma, non-small-cell lung | Gefitinib (Iressa) |
| EpCAM expression | Cancer ascites | Catumaxomab (Removab) |
| FIP1L1-PDGFR rearrangement | Hypereosinophilic syndrome | Imatinib (Glivec)‡ |
| G551D mutation in the CFTR gene | Cystic fibrosis | Ivacaftor (Kalydeco)† |
| Genotype 1 HCV | Hepatitis C, chronic | Boceprevir (Victrelis) |
| Genotype 1 HCV | Hepatitis C | Telaprevir (Incivo) |
| HER2 expression | Breast neoplasms | Lapatinib (Tyverb) |
| HER2 expression | Breast neoplasms | Trastuzumab (Herceptin) |
| HER2 expression | Stomach neoplasms | Trastuzumab (Herceptin) |
| HER2 expression | Breast neoplasms | Everolimus (Afinitor) |
| HER2 expression§ | Breast neoplasms | Pertuzumab (Perjeta) |
| Hormone dependency | Prostatic neoplasms | Degarelix (Firmagon) |
| Hormone receptor expression§ | Breast neoplasms | Zoledronic acid (Zometa) |
| Hormone receptor expression | Breast neoplasms | Everolimus (Afinitor) |
| Kit (CD 117) expression | Gastrointestinal stromal tumours | Imatinib (Glivec)‡ |
| Kit (D816V) mutation¶ | Aggressive systemic mastocytosis | Imatinib (Glivec)‡ |
| KRAS mutation | Colorectal neoplasms | Cetuximab (Erbitux) |
| KRAS mutation | Colorectal neoplasms | Panitumumab (Vectibix) |
| LPL protein detectable | Hyperlipoproteinaemia type I | Alipogene tiparvovec (Glybera)† |
| Oestrogen receptor expression | Breast neoplasms | Fulvestrant (Faslodex) |
| Oestrogen receptor expression | Breast neoplasms | Toremifene (Fareston) |
| PDGFR gene rearrangements | Myelodysplastic-myeloproliferative diseases | Imatinib (Glivec)‡ |
| Philadelphia chromosome | Precursor cell lymphoblastic leukaemia-lymphoma | Dasatinib (Sprycel)† |
| Philadelphia chromosome | Precursor Cell lymphoblastic leukaemia-lymphoma | Imatinib (Glivec)‡ |
| t(15; 17) translocation | Leukaemia, promyelocytic, acute | Arsenic trioxide (Trisenox)‡ |
| Viral resistance mutations¶ | HIV infections | Amprenavir (Agenerase) |
| Viral resistance mutations | HIV infections | Atazanavir sulfate (Reyataz) |
| Viral resistance mutations | HIV infections | Darunavir (Prezista) |
| Viral resistance mutations | HIV infections | Efavirenz/emtricitabine/tenofovir disoproxil (Atripla) |
| Viral resistance mutations | HIV infections | Emtricitabine (Emtriva) |
| Viral resistance mutations | HIV infections | Emtricitabine/rilpivirine/tenofovir disoproxil (Eviplera) |
| Viral resistance mutations | HIV infections | Enfuvirtide (Fuzeon) |
| Viral resistance mutations | HIV infections | Fosamprenavir calcium (Telzir) |
| Viral resistance mutations | HIV infections | Lopinavir/ritonavir (Kaletra) |
| Viral resistance mutations¶ | HIV infections | Nelfinavir (Viracept) |
| Viral resistance mutations | HIV infections | Rilpivirine hydrochloride (Edurant) |
| Viral resistance mutations | HIV infections | Tenofovir disoproxil fumarate (Viread) |
| Viral resistance mutations | HIV infections | Tipranavir (Aptivus) |
*Refused.
†Drug designated an orphan medicine.
‡Orphan designation has been removed at the end of exclusivity period.
§Pending.
¶Withdrawn.