Thyroid cancer
The EU has approved 9 indications of 7 drugs in thyroid cancer. 5 of them need a biomarker result: RET (3) and BRAF (2). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Histology
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRAF mutation2 | ||||
Tafinlar | V600E | + trametinib | 2L advanced | Differentiated thyroid cancer only; After prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |
Mekinist | V600E | + dabrafenib | 2L advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |
| RET3 | ||||
Retsevmo | Monotherapy | Any line advanced | Radioactive iodine-refractory (if radioactive iodine is appropriate); aged 2 years and older | |
Retsevmo | Monotherapy | Any line advanced | Medullary thyroid cancer only; Aged 2 years and older | |
Caprelsa | Monotherapy | Any line advanced | Medullary thyroid cancer only; Aggressive and symptomatic disease; aged 5 years and older | |
| No biomarker required4 | ||||
Cabometyx | None | Monotherapy | 2L advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory or not eligible to radioactive iodine (RAI) |
Cometriq | None | Monotherapy | Any line advanced | Medullary thyroid cancer only; Progressive disease |
Lenvima | None | Monotherapy | Any line advanced | Differentiated thyroid cancer only; Refractory to radioactive iodine (RAI); progressive disease |
Nexavar | None | Monotherapy | Any line advanced | Differentiated thyroid cancer only; Progressive; refractory to radioactive iodine |
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 thyroid cancer
Label wording9
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Cabozantinib (Cabometyx)
CABOMETYX is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.
- Cabozantinib (Cometriq)
COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
- Vandetanib (Caprelsa)
Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
- Selpercatinib (Retsevmo)
advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).
- Selpercatinib (Retsevmo)
advanced RET-mutant medullary thyroid cancer (MTC).
- Trametinib (Mekinist)
Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).
- Dabrafenib (Tafinlar)
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).
- Sorafenib (Nexavar)
Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
- Lenvatinib (Lenvima)
LENVIMA as monotherapy is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).