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TEVIMBRA (Beigene Aus Pty Ltd)
Product name
TEVIMBRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 (255 working days)
Active ingredients
tislelizumab
Registration type
NCE/NBE
Indication
Oesophageal squamous cell carcinoma (OSCC)
TEVIMBRA as monotherapy is indicated for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy.
Non-small cell lung cancer (NSCLC)
TEVIMBRA in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with PD-L1 expression ≥ 50% but no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
TEVIMBRA in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.
TEVIMBRA as monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy.