AstraZeneca’s Share Price Rose 3.89% on FDA’s Double Approval

The AstraZeneca plc (LON: AZN) share price rose 3.89% after the US Food and Drug Administration (FDA) officially accepted the Biologics License Application (BLA) submitted by AstraZeneca and Daiichi Sankyo for the innovative therapy datopotamab deruxtecan (Dato-DXd). 

This application seeks approval for the use of Dato-DXd in treating adults with advanced stages of nonsquamous non-small cell lung cancer (NSCLC) who have previously undergone systemic therapy. Under the Prescription Drug User Fee Act, the expected decision from the FDA is anticipated in the last quarter of 2024.

This submission is grounded on the compelling evidence from the TROPION-Lung01 Phase III clinical trial. In this study, datopotamab deruxtecan showcased a statistically significant enhancement in progression-free survival (PFS) over docetaxel, which is the existing treatment standard, among patients with advanced NSCLC who had received at least one prior therapy regimen.

Although the interim analysis of the overall survival (OS) endpoint showed datopotamab deruxtecan in a favourable light compared to docetaxel across the study population, statistical significance was not achieved during the interim data review.

For patients with nonsquamous NSCLC, datopotamab deruxtecan demonstrated a meaningful improvement in PFS and a positive trend towards better OS, albeit not statistically significant at this juncture. The study is still in progress, with a final analysis on OS pending.

The US Food and Drug Administration (FDA) has also granted approval for the use of AstraZeneca's Tagrisso (osimertinib) in combination with chemotherapy for adult patients facing locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFRm).

This endorsement comes after a Priority Review and is based on findings from the FLAURA2 Phase III clinical trial, as reported in The New England Journal of Medicine. 

The combination of Tagrisso and chemotherapy has been shown to decrease the risk of disease progression or death by 38% compared to the use of Tagrisso alone, which represents the first-line standard of care globally (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001).

The median progression-free survival (PFS) was extended to 25.5 months for those receiving the combined treatment, marking an 8.8-month increase over the 16.7 months observed with Tagrisso alone, according to the investigators' assessment.

AstraZeneca share price. 

The AstraZeneca share price rose 3.89% to trade at 10,499.0p from Friday’s closing price of 10,106.0p.