Glioma
The EU has approved 9 indications of 5 drugs in glioma. 8 of them need a biomarker result: BRAF (6) and IDH1/2 (2). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Grade
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF6 | ||||
Ojemdaconditional | Monotherapy | 2L | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older | |
Ojemdaconditional | V600 | Monotherapy | 2L | Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older |
Finlee | V600E | + trametinib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
Finlee | V600E | + trametinib | Any line | High-grade glioma only; Children and adolescents only; After at least one prior radiation and/or chemotherapy treatment; Aged 1 year and older |
Spexotras | V600E | + dabrafenib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
Spexotras | V600E | + dabrafenib | Any line | High-grade glioma only; Children and adolescents only; After at least one prior radiation and/or chemotherapy treatment; Aged 1 year and older |
| IDH1/2 mutation2 | ||||
Voranigo | IDH1 R132 or IDH2 R172 | Monotherapy | 1L | Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy |
Voranigo | R172 | Monotherapy | Any line | Grade 2 only; After surgical intervention only; Aged 12 years and older; weighing at least 40 kg; not in immediate need of radiotherapy or chemotherapy |
| No biomarker required1 | ||||
Votubia | None | Monotherapy | Any line | SEGA with tuberous sclerosis only; Tuberous sclerosis complex; require therapeutic intervention but are not amenable to surgery |
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 | |
Biomarkers in glioma
Label wording9
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Everolimus (Votubia)
Votubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to surgery.
- Vorasidenib (Voranigo)
Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).
- Vorasidenib (Voranigo)
Voranigo as monotherapy is indicated for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1).
- Trametinib (Spexotras)
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
- Trametinib (Spexotras)
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
- Dabrafenib (Finlee)
Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
- Dabrafenib (Finlee)
Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
- Tovorafenib (Ojemda)
Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).
- Tovorafenib (Ojemda)
Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).