Basal cell carcinoma

The EU has approved 4 indications of 3 drugs in basal 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, Basal cell carcinoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required4
Cemiplimab
Libtayo
None
Monotherapy
2L
advanced
Progressed on or intolerant to a hedgehog pathway inhibitor (HHI)
Sonidegib
Odomzo
None
Monotherapy
Any line
locally adv.
Not amenable to curative surgery or radiation therapy
Vismodegib
Erivedge
None
Monotherapy
Any line
metastatic
Symptomatic
Vismodegib
Erivedge
None
Monotherapy
Any line
locally adv.
Inappropriate for surgery or radiotherapy

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 wording4

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

  1. Vismodegib (Erivedge)
    Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
  2. Vismodegib (Erivedge)
    Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
  3. Cemiplimab (Libtayo)
    LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
  4. Sonidegib (Odomzo)
    Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.