Pancreatic cancer

The EU has approved 2 indications of 2 drugs in pancreatic cancer. 1 of them needs a biomarker result: BRCA1/2 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Line of therapy

Approved indications, Pancreatic cancer
DrugBiomarker requirementRegimenSettingConditions
BRCA1/2 mutation1
Olaparib
Lynparza
Germline BRCA1/2 mutation
Monotherapy
Maint.
metastatic
After minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen without progression
No biomarker required1
Erlotinib
Tarceva
None
+ gemcitabine
Any line
metastatic
None

Tumour-agnostic approvals6

Approved for any solid tumour that carries the alteration, wherever the tumour started.

DrugBiomarker requirementRegimenSettingConditions
EpCAM1
Monotherapy
2L
Malignant ascites; not eligible for further systemic anticancer therapy
HER21
Trastuzumab deruxtecan
Enhertuconditional
HER2-positive (IHC 3+)
Monotherapy
2L
advanced
After prior treatment; No satisfactory treatment options
NTRK fusion3
Entrectinib
Rozlytrekconditional
Monotherapy
Any line
No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Larotrectinib
Vitrakviconditional
Monotherapy
Any line
Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options
Repotrectinib
Augtyroconditional
Monotherapy
Any line
advanced
Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older
RET fusion1
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older

Biomarkers in pancreatic cancer

Label wording2

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Olaparib (Lynparza)
    monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
  2. Erlotinib (Tarceva)
    Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.