Oesophageal cancer
The EU has approved 21 indications of 11 drugs in oesophageal cancer. 13 of them need a biomarker result: PD-L1 (10), HER2 (2) and CLDN18.2 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Histology
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| CLDN18.2-positive1 | ||||
Vyloy | Claudin (CLDN) 18.2 positive, HER2-negative | + fluoropyrimidine- and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
| HER22 | ||||
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1L metastatic | Gastro-oesophageal junction adenocarcinoma only |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | Gastro-oesophageal junction adenocarcinoma only; After prior trastuzumab-based regimen |
| PD-L110 | ||||
Yervoy | Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1L advanced | Squamous cell carcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Squamous cell carcinoma only |
Opdivo | CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Adenocarcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + ipilimumab | 1L advanced | Squamous cell carcinoma only |
Keytruda | CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Keytruda | CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Hetronifly | CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
Tevimbra | TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | Gastro-oesophageal junction adenocarcinoma only |
Tevimbra | TAP score ≥ 5% | + platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
| No biomarker required8 | ||||
Imfinzi | None | + FLOT chemotherapy | Neoadj. early | Gastro-oesophageal junction adenocarcinoma only; Then adjuvant durvalumab + FLOT chemotherapy, followed by monotherapy after surgery |
Imfinzi | None | + FLOT chemotherapy, followed by monotherapy | Adj. early | Gastro-oesophageal junction adenocarcinoma only; After neoadjuvant durvalumab + FLOT chemotherapy and surgical resection |
Opdivo | None | Monotherapy | Adj. | After prior neoadjuvant chemoradiotherapy; Residual pathologic disease |
Loqtorzi | None | + cisplatin and paclitaxel | 1L advanced | Squamous cell carcinoma only |
Opdivo | None | Monotherapy | 2L advanced | Squamous cell carcinoma only; After prior fluoropyrimidine- and platinum-based combination chemotherapy |
Cyramza | None | + paclitaxel | 2L advanced | Gastro-oesophageal junction adenocarcinoma only; After platinum and fluoropyrimidine chemotherapy |
Cyramza | None | Monotherapy | 2L advanced | Gastro-oesophageal junction adenocarcinoma only; After platinum or fluoropyrimidine chemotherapy; For whom treatment in combination with paclitaxel is not appropriate |
Tevimbra | None | Monotherapy | 2L advanced | Squamous cell carcinoma only; After prior platinum-based chemotherapy |
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 oesophageal cancer
Label wording21
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
- Trastuzumab (Herceptin, Tuznue)
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
- Durvalumab (Imfinzi)
IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.
- Durvalumab (Imfinzi)
IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.
- Serplulimab (Hetronifly)
HETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).
- Tislelizumab (Tevimbra)
Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.
- Zolbetuximab (Vyloy)
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).
- Toripalimab (Loqtorzi)
LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.
- Ipilimumab (Yervoy)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Ramucirumab (Cyramza)
Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).
- Ramucirumab (Cyramza)
Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).