“As part of our commitment to bring innovative cancer medicines to more patients, we recently launched TEVIMBRA in EMA-approved indications in Germany, Austria and Norway, and we are working to make TEVIMBRA available across Europe.”
TEVIMBRA in Europe:
BeiGene recently launched TEVIMBRA in the first European countries following EU marketing authorizations for the treatment of eligible patients with ESCC and NSCLC. TEVIMBRA is also approved in the UK and Switzerland for eligible patients with advanced or metastatic ESCC.
“Advanced or metastatic ESCC and NSCLC are aggressive cancers with limited treatment options,” said Markus Moehler, M.D., Ph.D., of the Johannes Gutenberg University Medical Center Mainz in Germany. “The availability of tislelizumab for these patients represents an important next step to advance the treatment landscape.”
The European Commission approvals were based on the results from four randomized Phase 3 studies in the RATIONALE program: RATIONALE-302 (NCT03430843) for ESCC and RATIONALE-307 (NCT03594747), RATIONALE-304 (NCT03663205) and RATIONALE-303 (NCT03358875) for NSCLC. The approved indications for TEVIMBRA in the EU are:
In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
About TEVIMBRA® (tislelizumab):
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
About BeiGene:
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents.
For more information please visit www.beigene.com
