Daiichi Sankyo And AstraZeneca Announced Earlier, BLA For Datopotamab Deruxtecan Accepted By FDA, Potential First TROP2 Directed ADC For Non-Squamous NSCLC After Prior Therapy
Portfolio Pulse from Charles Gross
The FDA has accepted the Biologics License Application (BLA) for datopotamab deruxtecan, a potential first TROP2 directed antibody drug conjugate for non-squamous NSCLC after prior therapy, developed by Daiichi Sankyo and AstraZeneca. The application is based on results from the TROPION-Lung01 phase 3 trial.

February 19, 2024 | 3:56 pm
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POSITIVE IMPACT
AstraZeneca's collaboration with Daiichi Sankyo on datopotamab deruxtecan has led to the FDA accepting their BLA, potentially marking a significant advancement in NSCLC treatment.
The acceptance of the BLA by the FDA is a positive development for AstraZeneca, indicating progress in their oncology portfolio. This news is likely to be viewed favorably by investors, potentially leading to a short-term uptick in AstraZeneca's stock price.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90
POSITIVE IMPACT
Daiichi Sankyo's joint development with AstraZeneca, datopotamab deruxtecan, has received FDA acceptance for its BLA, positioning it as a pioneering treatment for NSCLC.
The FDA's acceptance of the BLA for datopotamab deruxtecan represents a significant milestone for Daiichi Sankyo, showcasing the potential of their collaboration with AstraZeneca. This development is likely to positively impact Daiichi Sankyo's stock in the short term, as it highlights their innovation in drug development.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90