On 17 October 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product tislelizumab (Tevimbra).
The marketing authorisation holder for this medicinal product is Beigene Ireland Limited.
The CHMP adopted new indications to extend the use of Tevimbra to patients with previously untreated gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, and to patients with previously untreated oesophageal squamous cell carcinoma (OSCC), as follows:
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5%.
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%.
For information, the full indications for Tevimbra will be as follows (new indications in bold):
Non-small cell lung cancer (NSCLC)
Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK alterations and who have:
- locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
- metastatic NSCLC.
Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:
- locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
- metastatic NSCLC.
Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR-mutated or ALK-positive NSCLC should also have received targeted therapies before receiving tislelizumab.
Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumours express PD-L1 with a TAP score ≥ 5%.
Oesophageal squamous cell carcinoma (OSCC)
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%.
Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report and made available in all official European Union languages after a decision on these changes to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.