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FDA starts speedy review of Amgen’s lung cancer BiTE therapy

December 14, 2023

Tarlatamab is under review as a treatment for adult patients with advanced SCLC who have disease progression on or after platinum-based chemotherapy, with the FDA due to deliver a decision on the marketing application by 12th June next year. The drug also has a breakthrough designation from the regulator.

BiTE drugs are designed to engage the immune system against cancer by the expedient of bringing T cells and cancer cells into close proximity. In the case of tarlatamab, the molecule binds to CD3 receptors on T cells and DLL3 on SCLC cells with the aim of stimulating the immune system to destroy the tumour.

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