After a long review tislelizumab makes EU progress

BeiGene’s anti-PD-1 drug tislelizumab has spent nearly two years in US regulatory limbo, and that’s not the only region where review has suffered long delays. The EU CHMP on Friday came out with a positive opinion on three tislelizumab lung cancer indications – all of which the EMA had validated for review back in April 2022. US regulatory decisions were delayed by Covid-related travel restrictions making FDA inspections of China-based manufacturing facilities impossible, but in the EU the drug did obtain its first western approval last September, as Tevimbra, for second-line oesophageal squamous cell carcinoma; that review had taken 17 months, and came at the same time as Novartis terminated its licensing deal. Notably, both trials that will support first-line NSCLC approvals in the EU were conducted in China – a strategy that the FDA has made clear won’t work in the US for anything beyond niche indications. Details just revealed include a different trade name for tislelizumab – Tizveni – and the fact that in first-line non-squamous NSCLC, a filing supported by the Rationale-304 study, the EMA will limit approval to patients whose cancers express PD-L1 at ≥50%.

Tislelizumab's slow progress in the west

Note: *BeiGene has clarified that Tizveni was the trade name used in Novartis's original NSCLC filing; with rights reverting to BeiGene the aim is to merge the marketing authorisations under the trade name Tevimbra across all EU indications. Source: OncologyPipeline.