AstraZeneca PLC and Daiichi Sankyo Co., Ltd. presented data on 8 and 9 September that seem to support their decision to seek US Food and Drug Administration approval for their TROP2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line or later treatment for non-small cell lung cancer (NSCLC), but only in patients with non-squamous histology. The FDA is expected to make its approval decision by 20 December.
Key Takeaways
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AstraZeneca and Daiichi Sankyo anticipate a US FDA approval decision later this year for their TROP2 ADC Dato-DXd in second-line treatment of non-squamous NSCLC, reflecting a subpopulation of the Phase III TROPION-Lung01 study in which overall survival was higher than in the broader group.
The drug makers reported TROP2 biomarker prevalence, per quantitative continuous scoring (QCS) in NSCLC patients enrolled in the Phase III...