LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Monday said its supplemental New
Drug Application (sNDA) for Tagrisso has been granted priority review in the US
for the treatment of adult patients with unresectable, Stage III epidermal
growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after
chemoradiotherapy.

A decision from the regulator is expected in the fourth quarter of 2024.

The sNDA was based on data from the LAURA Phase III trial, which showed
treatment with Tagrisso reduced the risk of disease progression or death by 84
percent compared to placebo.

Tagrisso was also recently granted Breakthrough Therapy Designation (BTD) by the
FDA in this setting.

Tagrisso is approved as monotherapy in more than 100 countries including in the
US, EU, China and Japan in indications including 1st-line treatment of patients
with EGFRm NSCLC, EGFR T790M mutation-positive NSCLC, and adjuvant treatment of
early-stage EGFRm NSCLC. Tagrisso plus chemotherapy is also approved in the US
and several other countries for 1st-line treatment of patients with EGFRm NSCLC.



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