Merkel cell carcinoma

The EU has approved 2 indications of 2 drugs in merkel cell carcinoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Line of therapy

Approved indications, Merkel cell carcinoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required2
None
Monotherapy
1L
advanced
Not amenable to curative surgery or radiation therapy
Avelumab
Bavencio
None
Monotherapy
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
Label wording2

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

  1. Avelumab (Bavencio)
    Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
  2. Retifanlimab (Zynyz)
    ZYNYZ is indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.