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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