6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and Japan.

BeiGene today announced that marketing authorisation applications for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the EMA for patients with advanced or metastatic oesophageal squamous cell carcinoma after prior systemic chemotherapy and for patients with non-small-cell lung cancer including:

• As monotherapy for the treatment of locally advanced or metastatic non-small-cell lung cancer after prior chemotherapy in adults
• In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous non-small-cell lung cancer in adults
• In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous non-small-cell lung cancer in adults whose tumours have no EGFR or ALK positive mutations

Read BeiGene press release