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Novartis's Tislelizumab Takes First Step On US Approval Path

Aiming To Reach Crowded Checkpoint Inhibitor Market

 
• By Kevin Grogan

Novartis has filed the PD-1 inhibitor tislelizumab, licensed from BeiGene, for second-line esophageal cancer with the FDA, the first submission outside China for the closely-watched therapy.

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Big step for Novartis's plans with tislelizumab

Novartis AG's plans to get a slice of the global anti-PD-1/L1 market have advanced with the news that the US Food and Drug Administration has accepted a submission for tislelizumab, licensed from China's BeiGene, Ltd., as a treatment for esophageal cancer.

The agency has set a Prescription Drug User Fee Act target action date of July 12 next year for its evaluation of anti-PD-1 immune checkpoint inhibitor tislelizumab for the treatment...

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