Tislelizumab (9) – Tevimbra®

Non-small cell lung cancer, high risk of recurrence, neoadjuvant and adjuvant therapy, monotherapy or in combination with platinum-based chemotherapy

Characteristics

Start date 01.10.2025 – Marketing authorisation: 21.08.2025
Resolution 19.03.2026
INN Tislelizumab
Brand name Tevimbra®
Pharm. company BeOne Medicines Germany GmbH
G-BA Procedure ID D-1251
ATC code L01FF09 PD-1/PDL-1 inhibitors (L01FF)
ICD-10 codes (AIS) C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung
Alpha-ID codes (AIS) I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas
Therapeutic area Oncological diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Tislelizumab (Tevimbra) is indicated in combination with platinum-based chemotherapy for neoadjuvant treatment and subsequently as monotherapy for adjuvant treatment of resectable NSCLC with a high risk of recurrence in adult patients.
Subpopulation Indication Comparator
Erwachsene mit resezierbarem NSCLC mit hohem Rezidivrisiko; neoadjuvante und adjuvante Therapie

Studies and Results

Adults with resectable NSCLC at high risk of recurrence; neoadjuvant and adjuvant therapy

  • An additional benefit is not proven.
  • The pharmaceutical manufacturer has not provided any data for the assessment of additional benefit regarding the treatment of adults with resectable NSCLC and a high risk of recurrence using tislelizumab in combination with platinum-based chemotherapy for neoadjuvant treatment and subsequently as monotherapy for adjuvant treatment. Consequently, additional benefit is not proven.

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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