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Approval Alert: BeiGene’s Tevimbra® (Tislelizumab) Approved in New Zealand

Dec 5, 2024

On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s Tevimbra® (Tislelizumab) for the following indications:

  • as monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced or metastatic OSCC after prior systemic therapy;
  • as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy;
  • in combination with pemetrexed and platinum containing chemotherapy for first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC, with PD-L1 expression greater than or equal to 50% but no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations; and
  • in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.

This news follows EU approval of Tevimbra® in combination with chemotherapy for the first-line treatment of oesophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (November 2024).  BeiGene has also sought Australian approval of Tevimbra® for the treatment of recurrent or metastatic nasopharyngeal carcinoma (July 2024).