AstraZeneca’s Osimertinib Receives FDA Priority Review for Adjuvant Treatment of Early-Stage EGFR-Mutated NSCLC

Today, AstraZeneca announced that the U.S. FDA has granted Priority Review status to its supplemental New Drug Application (sNDA) for a new indication of osimertinib (Tagrisso), with a PDUFA action date scheduled for the first quarter of 2021. The new indication is for the adjuvant treatment of patients with early-stage (Stage IB, II, and IIIA) epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC) following curative tumor resection. The press release highlighted the striking results from the Phase III ADAURA clinical trial, which demonstrated that treatment with osimertinib reduced the risk of disease recurrence or death by 80%.

Although up to 30% of patients with non-small cell lung cancer (NSCLC) can be diagnosed at an early stage and undergo potentially curative surgery, disease recurrence remains common in early-stage disease. Nearly half of patients diagnosed with stage IB NSCLC and more than three-quarters of those diagnosed with stage IIIA NSCLC experience recurrence within five years. This supplemental New Drug Application (sNDA) is based on the results of the Phase 3 ADAURA trial, which demonstrated statistically significant and clinically meaningful improvements in disease-free survival (DFS) both in the primary analysis population of patients with stage II and IIIA EGFR-mutated (EGFRm) NSCLC and in the overall trial population of patients with stage IB–IIIA NSCLC.

In April 2020, the Independent Data Monitoring Committee recommended unblinding the ADAURA trial two years ahead of schedule, based on the overwhelming efficacy of osimertinib in the adjuvant treatment of lung cancer after surgery. Investigators and patients continued to participate in the trial while remaining blinded to treatment assignments. The results of the ADAURA trial were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in May and were recently published in The New England Journal of Medicine. In this context, osimertinib (Tagrisso) received Breakthrough Therapy Designation (BTD) in the United States in July.

Osimertinib is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases. It has been approved in the United States, Japan, China, the European Union, and many other countries worldwide for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC. Notably, last week, the National Medical Products Administration (NMPA) of China included the indication for adjuvant treatment of adult patients with EGFR-sensitive mutation-positive NSCLC following tumor resection in its list of drugs proposed for priority review.

References:

[1] Tagrisso granted Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer. Retrieved 2020-10-20, from https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-adjuvant-lung-cancer-us-priority-review.html

Source: Jike Pharma News

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