Tislelizumab (1) – Tevimbra®

Squamous cell carcinoma of the oesophagus, after prior therapy

Characteristics

Start date 01.01.2025 – Marketing authorisation: 15.09.2023
Resolution 18.06.2025
INN Tislelizumab
Brand name Tevimbra®
Pharm. company BeiGene Germany GmbH
G-BA Procedure ID D-1125
ATC code L01FF09 PD-1/PDL-1 inhibitors (L01FF)
Therapeutic area Oncological diseases
Reason for procedure Initial assessment
Specialty Bundling ACT change

Studies and Results

  • Clinical trials
    • The pharmaceutical manufacturer submitted the results of the RATIONALE 302 randomised controlled trial for the benefit assessment of tislelizumab for the treatment of adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy.
    • The RATIONALE 302 study is an open-label Phase III trial comparing tislelizumab with treatment at the clinician’s discretion, selected from docetaxel, paclitaxel and irinotecan.

Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy

  • Additional benefit is not proven for tislelizumab in the treatment of adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus following prior platinum-based chemotherapy.

Courtesy translation only, please refer to the German original.

Associated procedures

Tislelizumab (9) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy 5,090–5,780 100% additional benefit not proven
Tislelizumab (8) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Recurrent or metastatic nasopharyngeal carcinoma (NPC), first-line treatment, in combination with gemcitabine and cisplatin 70–120 100% additional benefit not proven
Tislelizumab (7) Tevimbra® BeOne Medicines Germany GmbH Oncological diseases Small cell lung cancer, first-line treatment, in combination with etoposide and platinum-based chemotherapy 3,820–8,124 100% additional benefit not proven
Tislelizumab (6) Tevimbra® BeiGene Germany GmbH Oncological diseases Adenocarcinoma of the stomach or gastro-oesophageal junction, PD-L1 expression ≥ 5, HER2-, first-line, combination with platinum- and fluoropyrimidine-based chemotherapy 1,941–3,067 100% additional benefit not proven
Tislelizumab (4) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, after prior therapy 690–1,620 100% additional benefit not proven
Tislelizumab (2) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, non-squamous, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-containing chemotherapy 3,460–4,600 100% additional benefit not proven
Tislelizumab (3) Tevimbra® BeiGene Germany GmbH Oncological diseases Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel 7,780–11,040 100% additional benefit not proven
Tislelizumab (5) Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, PD-L1 expression TAP score ≥ 5%, first-line, combination with platinum-based chemotherapy 1,530–2,050 100% additional benefit not proven
Tislelizumab (1) Tevimbra® BeiGene Germany GmbH Oncological diseases Squamous cell carcinoma of the oesophagus, after prior therapy 330–540 100% additional benefit not proven


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