Soft tissue sarcoma
The EU has approved 3 indications of 3 drugs in soft tissue sarcoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Subtype
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| No biomarker required3 | ||||
Votrient | None | Monotherapy | 2L advanced | After prior chemotherapy for metastatic disease or progression within 12 months after (neo)adjuvant therapy; Selective subtypes of advanced soft-tissue sarcoma |
Glivec | None | Monotherapy | Any line advanced | Dermatofibrosarcoma protuberans only; Not eligible for surgery (for recurrent and/or metastatic DFSP) |
Beromun | None | + melphalan via mild hyperthermic isolated limb perfusion (ILP) | Any line advanced | As an adjunct to surgery for subsequent removal of the tumour to prevent or delay amputation, or in the palliative situation |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
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 | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
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 | ||||
Retsevmo | 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.
- Imatinib (Glivec)
the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
- Tasonermin (Beromun)
Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).
- Pazopanib (Votrient)
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.