(RTTNews) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that its Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application or sNDA and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.
The Food and Drug Administration's review is for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated or EGFRm non-small cell lung cancer or NSCLC after complete tumour resection with curative intent.
The sNDA was based on results from the ADAURA Phase III trial showing Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, and also in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.
The company noted that while up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease. Nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2021.
In April 2020 , an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early, based on its determination of overwhelming efficacy. Investigators and patients continue to participate in the trial and remain blinded to treatment.
Tagrisso received Breakthrough Therapy Designation in this setting in July 2020.
The drug is approved for both the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries.
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