Mesothelioma

The EU has approved 3 indications of 3 drugs in mesothelioma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

Histology

Site

Line of therapy

Approved indications, Mesothelioma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required3
None
+ nivolumab
1L
advanced
Pleural mesothelioma only
Nivolumab
Opdivo
None
+ ipilimumab
1L
advanced
Pleural mesothelioma only
None
+ pemetrexed and platinum chemotherapy
1L
advanced
Non-epithelioid only; Pleural mesothelioma only

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 wording3

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

  1. Pembrolizumab (Keytruda)
    KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
  2. Nivolumab (Opdivo)
    OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
  3. Ipilimumab (Yervoy)
    YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.