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.
AstraZeneca/Daiichi Make Their Case For Dato-DXd In Non-Squamous Lung Cancer
Early-Stage PD-L1/Chemo Combo Data Also Reported
Data at WCLC showed why the TROP2-targeting ADC datopotamab deruxtecan is most effective in non-squamous NSCLC in second or later lines as presented in overall survival data at the meeting.
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A decision from the FDA is due by 28 September.