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AstraZeneca's sNDA for Tagrisso in Adjuvant, EGFR-Mutated Lung Cancer Accepted by FDA

NEW YORK – The US Food and Drug Administration has accepted AstraZeneca's supplemental new drug application for osimertinib (Tagrisso) as an adjuvant treatment for early-stage, EGFR-mutated non-small cell lung cancer patients after they've had surgery to completely remove their tumors.

AstraZeneca submitted data from the Phase III ADAURA trial, in which adjuvant osimertinib improved disease-free survival in EGFR-mutated NSCLC patients with stage I to stage IIIA disease compared to placebo. After two years of treatment, the disease-free survival rate among patients in the osimertinib arm was 89 percent versus 53 percent for those in the placebo arm. When the analysis was restricted to patients with stage II or more advanced disease, osimertinib reduced the risk of disease recurrence by 83 percent.

In April, based on the promising efficacy seen in ADAURA, an independent data monitoring committee recommended the study be unblinded. However, when the results were presented at the American Society of Clinical Oncology's annual meeting, the study sparked significant debate, with some oncologists pointing out that the data to date provides no assurance that the disease-free survival benefit seen with adjuvant osimertinib treatment will translate into a survival advantage, and actually allow cancer patients to live longer. The overall survival analysis in ADAURA is not yet mature. 

Up to 30 percent of NSCLC patients are diagnosed at an early stage and receive surgery, but it's not curative for all. Within five years of diagnosis, nearly half of patients with stage IB lung cancer and more than 75 percent of those with stage IIIA disease experience recurrence. "Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients," Dave Fredrickson, AstraZeneca's executive VP of the oncology business unit, said in a statement.

In accepting the sNDA for osimertinib, the FDA has granted the application priority review and is slated to issue a decision in the first quarter of 2021.

Osimertinib is already approved in the US, EU, Japan, and China as a first-line option for metastatic, EGFR-mutated NSCLC patients and for metastatic NSCLC patients with the EGFR T790M resistance mutation.