EU gap
How long biomarker therapies take to reach the EU
For every therapy approved for a biomarker on marked.bio, when the FDA approved it, and when, or whether, the European Union followed.
- Approved in the US
- 113
- Also approved in the EU
- 62%
- Typical delay
- 1 yr
- US approvals since 2022 in the EU
- 24 of 54
therapy and tumour pairs
70 of 113
median, when the EU followed
recent approvals take time to follow
Every therapy, US and EU approval year
One row per drug or regimen and tumour type. FDA EU The line is the gap. Rows without an EU mark are not approved in the EU. Years only, so a gap of 0 can still be several months.
erdafitinib
urothelial · FGFR3 alteration (mutation or fusion) +5 yr
urothelial · FGFR3 alteration (mutation or fusion) +5 yr
olaparib
ovarian · BRCA1/2 mutation +5 yr
ovarian · BRCA1/2 mutation +5 yr
nivolumab with ipilimumab
colorectal · MSI-H / dMMR +3 yr
colorectal · MSI-H / dMMR +3 yr
tovorafenib
paediatric low-grade glioma · BRAF V600E +2 yr
paediatric low-grade glioma · BRAF V600E +2 yr
repotrectinib
NSCLC · ROS1 fusion +2 yr
NSCLC · ROS1 fusion +2 yr
adagrasib
NSCLC · KRAS G12C +2 yr
NSCLC · KRAS G12C +2 yr
selpercatinib
solid tumours (tumour-agnostic) · RET fusion or mutation +2 yr
solid tumours (tumour-agnostic) · RET fusion or mutation +2 yr
ivosidenib
cholangiocarcinoma · IDH1/2 mutation +2 yr
cholangiocarcinoma · IDH1/2 mutation +2 yr
capmatinib
NSCLC · MET exon 14 skipping +2 yr
NSCLC · MET exon 14 skipping +2 yr
rucaparib
ovarian · BRCA1/2 mutation +2 yr
ovarian · BRCA1/2 mutation +2 yr
alectinib
NSCLC · ALK fusion +2 yr
NSCLC · ALK fusion +2 yr
imlunestrant
breast (ER+/HER2-) · ESR1 mutation +1 yr
breast (ER+/HER2-) · ESR1 mutation +1 yr
lazertinib with amivantamab
NSCLC · EGFR exon 19 deletion / L858R +1 yr
NSCLC · EGFR exon 19 deletion / L858R +1 yr
repotrectinib
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
vorasidenib
glioma (grade 2) · IDH1/2 mutation +1 yr
glioma (grade 2) · IDH1/2 mutation +1 yr
encorafenib with binimetinib
NSCLC · BRAF V600E +1 yr
NSCLC · BRAF V600E +1 yr
ivosidenib with azacitidine
AML · IDH1/2 mutation +1 yr
AML · IDH1/2 mutation +1 yr
trastuzumab deruxtecan
NSCLC · HER2 (ERBB2) activating mutation +1 yr
NSCLC · HER2 (ERBB2) activating mutation +1 yr
trastuzumab deruxtecan
breast · HER2-low / ultralow (IHC 1+ or 2+/ISH-) +1 yr
breast · HER2-low / ultralow (IHC 1+ or 2+/ISH-) +1 yr
crizotinib
anaplastic large cell lymphoma · ALK fusion +1 yr
anaplastic large cell lymphoma · ALK fusion +1 yr
sotorasib
NSCLC · KRAS G12C +1 yr
NSCLC · KRAS G12C +1 yr
tepotinib
NSCLC · MET exon 14 skipping +1 yr
NSCLC · MET exon 14 skipping +1 yr
pembrolizumab
colorectal · MSI-H / dMMR +1 yr
colorectal · MSI-H / dMMR +1 yr
pemigatinib
cholangiocarcinoma · FGFR2 fusion or rearrangement +1 yr
cholangiocarcinoma · FGFR2 fusion or rearrangement +1 yr
pralsetinib
NSCLC · RET fusion or mutation +1 yr
NSCLC · RET fusion or mutation +1 yr
selpercatinib
NSCLC · RET fusion or mutation +1 yr
NSCLC · RET fusion or mutation +1 yr
selpercatinib
medullary thyroid · RET fusion or mutation +1 yr
medullary thyroid · RET fusion or mutation +1 yr
selpercatinib
thyroid · RET fusion or mutation +1 yr
thyroid · RET fusion or mutation +1 yr
alpelisib with fulvestrant
breast (HR+/HER2-) · PIK3CA activating mutation +1 yr
breast (HR+/HER2-) · PIK3CA activating mutation +1 yr
entrectinib
NSCLC · ROS1 fusion +1 yr
NSCLC · ROS1 fusion +1 yr
entrectinib
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
olaparib
pancreatic · BRCA1/2 mutation +1 yr
pancreatic · BRCA1/2 mutation +1 yr
dacomitinib
NSCLC · EGFR exon 19 deletion / L858R +1 yr
NSCLC · EGFR exon 19 deletion / L858R +1 yr
gilteritinib
AML · FLT3 mutation (ITD/TKD) +1 yr
AML · FLT3 mutation (ITD/TKD) +1 yr
larotrectinib
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
solid tumours (tumour-agnostic) · NTRK1/2/3 fusion +1 yr
lorlatinib
NSCLC · ALK fusion +1 yr
NSCLC · ALK fusion +1 yr
olaparib
breast · BRCA1/2 mutation +1 yr
breast · BRCA1/2 mutation +1 yr
talazoparib
breast · BRCA1/2 mutation +1 yr
breast · BRCA1/2 mutation +1 yr
brigatinib
NSCLC · ALK fusion +1 yr
NSCLC · ALK fusion +1 yr
ceritinib
NSCLC · ALK fusion +1 yr
NSCLC · ALK fusion +1 yr
dabrafenib with trametinib
melanoma · BRAF V600E +1 yr
melanoma · BRAF V600E +1 yr
crizotinib
NSCLC · ALK fusion, ROS1 fusion +1 yr
NSCLC · ALK fusion, ROS1 fusion +1 yr
vemurafenib
melanoma · BRAF V600E +1 yr
melanoma · BRAF V600E +1 yr
amivantamab with carboplatin + pemetrexed
NSCLC · EGFR exon 19 deletion / L858R, EGFR exon 20 insertion same year
NSCLC · EGFR exon 19 deletion / L858R, EGFR exon 20 insertion same year
amivantamab with lazertinib
NSCLC · EGFR exon 19 deletion / L858R same year
NSCLC · EGFR exon 19 deletion / L858R same year
durvalumab with carboplatin + paclitaxel, then durvalumab
endometrial · MSI-H / dMMR same year
endometrial · MSI-H / dMMR same year
osimertinib with pemetrexed + platinum chemotherapy
NSCLC · EGFR exon 19 deletion / L858R same year
NSCLC · EGFR exon 19 deletion / L858R same year
zolbetuximab with fluoropyrimidine + platinum chemotherapy
gastric/GEJ · Claudin 18.2 expression same year
gastric/GEJ · Claudin 18.2 expression same year
dabrafenib with trametinib
paediatric low-grade glioma · BRAF V600E same year
paediatric low-grade glioma · BRAF V600E same year
dostarlimab with carboplatin + paclitaxel
endometrial · MSI-H / dMMR same year
endometrial · MSI-H / dMMR same year
elacestrant
breast (ER+/HER2-) · ESR1 mutation same year
breast (ER+/HER2-) · ESR1 mutation same year
niraparib with abiraterone acetate + prednisone
prostate · BRCA1/2 mutation same year
prostate · BRCA1/2 mutation same year
quizartinib with standard induction and consolidation chemotherapy
AML · FLT3 mutation (ITD/TKD) same year
AML · FLT3 mutation (ITD/TKD) same year
crizotinib
inflammatory myofibroblastic tumour · ALK fusion same year
inflammatory myofibroblastic tumour · ALK fusion same year
pembrolizumab
endometrial · MSI-H / dMMR same year
endometrial · MSI-H / dMMR same year
amivantamab
NSCLC · EGFR exon 20 insertion same year
NSCLC · EGFR exon 20 insertion same year
dostarlimab
endometrial · MSI-H / dMMR same year
endometrial · MSI-H / dMMR same year
encorafenib with cetuximab
colorectal · BRAF V600E same year
colorectal · BRAF V600E same year
olaparib with bevacizumab
ovarian · BRCA1/2 mutation same year
ovarian · BRCA1/2 mutation same year
olaparib
prostate · BRCA1/2 mutation same year
prostate · BRCA1/2 mutation same year
ramucirumab with erlotinib
NSCLC · EGFR exon 19 deletion / L858R same year
NSCLC · EGFR exon 19 deletion / L858R same year
encorafenib with binimetinib
melanoma · BRAF V600E same year
melanoma · BRAF V600E same year
osimertinib
NSCLC · EGFR exon 19 deletion / L858R same year
NSCLC · EGFR exon 19 deletion / L858R same year
dabrafenib with trametinib
NSCLC · BRAF V600E same year
NSCLC · BRAF V600E same year
midostaurin with standard induction and consolidation chemotherapy
AML · FLT3 mutation (ITD/TKD) same year
AML · FLT3 mutation (ITD/TKD) same year
cobimetinib with vemurafenib
melanoma · BRAF V600E same year
melanoma · BRAF V600E same year
afatinib
NSCLC · EGFR exon 19 deletion / L858R same year
NSCLC · EGFR exon 19 deletion / L858R same year
dabrafenib
melanoma · BRAF V600E same year
melanoma · BRAF V600E same year
aumolertinib
NSCLC · EGFR exon 19 deletion / L858R EU only
NSCLC · EGFR exon 19 deletion / L858R EU only
capivasertib with fulvestrant
breast (ER+/HER2-) · PIK3CA activating mutation EU only
breast (ER+/HER2-) · PIK3CA activating mutation EU only
dabrafenib with trametinib
differentiated thyroid cancer · BRAF V600E EU only
differentiated thyroid cancer · BRAF V600E EU only
encorafenib with cetuximab + FOLFOX
colorectal · BRAF V600E EU only
colorectal · BRAF V600E EU only
futibatinib
cholangiocarcinoma · FGFR2 fusion or rearrangement EU only
cholangiocarcinoma · FGFR2 fusion or rearrangement EU only
inavolisib with palbociclib + fulvestrant
breast (ER+/HER2-) · PIK3CA activating mutation EU only
breast (ER+/HER2-) · PIK3CA activating mutation EU only
pembrolizumab
gastric; small intestine; biliary · MSI-H / dMMR EU only
gastric; small intestine; biliary · MSI-H / dMMR EU only
erlotinib
NSCLC · EGFR exon 19 deletion / L858R EU 2 yr earlier
NSCLC · EGFR exon 19 deletion / L858R EU 2 yr earlier
gefitinib
NSCLC · EGFR exon 19 deletion / L858R EU 6 yr earlier
NSCLC · EGFR exon 19 deletion / L858R EU 6 yr earlier
atezolizumab with fluoropyrimidine + oxaliplatin
colon · MSI-H / dMMR Not in the eu
colon · MSI-H / dMMR Not in the eu
camizestrant with CDK4/6 inhibitor
breast (HR+/HER2-) · ESR1 mutation Not in the eu
breast (HR+/HER2-) · ESR1 mutation Not in the eu
dostarlimab
rectal · MSI-H / dMMR Not in the eu
rectal · MSI-H / dMMR Not in the eu
imlunestrant with abemaciclib
breast (ER+/HER2-) · ESR1 mutation Not in the eu
breast (ER+/HER2-) · ESR1 mutation Not in the eu
lirafugratinib
cholangiocarcinoma · FGFR2 fusion or rearrangement Not in the eu
cholangiocarcinoma · FGFR2 fusion or rearrangement Not in the eu
vepdegestrant
breast (ER+/HER2-) · ESR1 mutation Not in the eu
breast (ER+/HER2-) · ESR1 mutation Not in the eu
zenocutuzumab
cholangiocarcinoma · NRG1 fusion Not in the eu
cholangiocarcinoma · NRG1 fusion Not in the eu
zidesamtinib
NSCLC · ROS1 fusion Not in the eu
NSCLC · ROS1 fusion Not in the eu
avutometinib + defactinib
low-grade serous ovarian · KRAS G12C Not in the eu
low-grade serous ovarian · KRAS G12C Not in the eu
datopotamab deruxtecan
NSCLC · EGFR exon 19 deletion / L858R Not authorised in the eu
NSCLC · EGFR exon 19 deletion / L858R Not authorised in the eu
revumenib
AML · NPM1 mutation Not in the eu
AML · NPM1 mutation Not in the eu
sevabertinib
NSCLC · HER2 (ERBB2) activating mutation Not in the eu
NSCLC · HER2 (ERBB2) activating mutation Not in the eu
sotorasib with panitumumab
colorectal · KRAS G12C Not in the eu
colorectal · KRAS G12C Not in the eu
sunvozertinib
NSCLC · EGFR exon 20 insertion Not in the eu
NSCLC · EGFR exon 20 insertion Not in the eu
taletrectinib
NSCLC · ROS1 fusion Under eu review
NSCLC · ROS1 fusion Under eu review
ziftomenib
AML · NPM1 mutation Not in the eu
AML · NPM1 mutation Not in the eu
zongertinib
NSCLC · HER2 (ERBB2) activating mutation Not in the eu
NSCLC · HER2 (ERBB2) activating mutation Not in the eu
adagrasib with cetuximab
colorectal · KRAS G12C Not in the eu
colorectal · KRAS G12C Not in the eu
encorafenib with cetuximab + fluorouracil-based chemotherapy
colorectal · BRAF V600E Not in the eu
colorectal · BRAF V600E Not in the eu
ensartinib
NSCLC · ALK fusion Under eu review
NSCLC · ALK fusion Under eu review
inavolisib with palbociclib + fulvestrant
breast (HR+/HER2-) · PIK3CA activating mutation Not in the eu
breast (HR+/HER2-) · PIK3CA activating mutation Not in the eu
zenocutuzumab
NSCLC · NRG1 fusion Not in the eu
NSCLC · NRG1 fusion Not in the eu
zenocutuzumab
pancreatic · NRG1 fusion Not in the eu
pancreatic · NRG1 fusion Not in the eu
capivasertib with fulvestrant
breast (HR+/HER2-) · PIK3CA activating mutation Not in the eu
breast (HR+/HER2-) · PIK3CA activating mutation Not in the eu
ivosidenib
MDS · IDH1/2 mutation Not in the eu
MDS · IDH1/2 mutation Not in the eu
olaparib with abiraterone + prednisone
prostate · BRCA1/2 mutation Not in the eu
prostate · BRCA1/2 mutation Not in the eu
talazoparib with enzalutamide
prostate · BRCA1/2 mutation Not in the eu
prostate · BRCA1/2 mutation Not in the eu
dabrafenib with trametinib
solid tumours (tumour-agnostic) · BRAF V600E Not in the eu
solid tumours (tumour-agnostic) · BRAF V600E Not in the eu
futibatinib
cholangiocarcinoma (intrahepatic) · FGFR2 fusion or rearrangement Not in the eu
cholangiocarcinoma (intrahepatic) · FGFR2 fusion or rearrangement Not in the eu
olutasidenib
AML · IDH1/2 mutation Not in the eu
AML · IDH1/2 mutation Not in the eu
dostarlimab
solid tumours (tumour-agnostic) · MSI-H / dMMR Not in the eu
solid tumours (tumour-agnostic) · MSI-H / dMMR Not in the eu
infigratinib
cholangiocarcinoma · FGFR2 fusion or rearrangement Not in the eu
cholangiocarcinoma · FGFR2 fusion or rearrangement Not in the eu
mobocertinib
NSCLC · EGFR exon 20 insertion Not in the eu
NSCLC · EGFR exon 20 insertion Not in the eu
atezolizumab with cobimetinib + vemurafenib
melanoma · BRAF V600E Not in the eu
melanoma · BRAF V600E Not in the eu
pralsetinib
medullary thyroid · RET fusion or mutation Not in the eu
medullary thyroid · RET fusion or mutation Not in the eu
rucaparib
prostate · BRCA1/2 mutation Not in the eu
prostate · BRCA1/2 mutation Not in the eu
dabrafenib with trametinib
anaplastic thyroid cancer · BRAF V600E Not in the eu
anaplastic thyroid cancer · BRAF V600E Not in the eu
ivosidenib
AML · IDH1/2 mutation Not in the eu
AML · IDH1/2 mutation Not in the eu
enasidenib
AML · IDH1/2 mutation Not in the eu
AML · IDH1/2 mutation Not in the eu
niraparib
ovarian · BRCA1/2 mutation Not in the eu
ovarian · BRCA1/2 mutation Not in the eu
nivolumab
colorectal · MSI-H / dMMR Not in the eu
colorectal · MSI-H / dMMR Not in the eu
pembrolizumab
solid tumours (tumour-agnostic) · MSI-H / dMMR Not in the eu
solid tumours (tumour-agnostic) · MSI-H / dMMR Not in the eu
vemurafenib
Erdheim-Chester disease · BRAF V600E Not in the eu
Erdheim-Chester disease · BRAF V600E Not in the eu
Built from the approvals on marked.bio: FDA and EMA (centralised EU) approvals for biomarker-selected indications, by year of first approval in that setting. A therapy can be available in some EU countries through other routes. "Not approved" means we found no EU approval for this indication.