AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation.
According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor receptor (EGFR) mutations. These mutations occur on a protein that leads to rapid cell growth, and subsequently, helps in the spread of cancer.
The FDA said that although most patients who are diagnosed with non-small cell lung cancer have tumors that cannot be removed, 30% have resectable disease. This means more than 10,000 patients across the US each year can be candidates for Tagrisso as adjuvant therapy after removal of their tumor.
Richard Pazdur – director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research said: “Today’s approval of Tagrisso demonstrates how additional research on therapies approved in later stages of cancer can eventually improve treatment options for patients in earlier stages.
“With this approval, patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer.”
Tagrisso was studied in a randomized, double-blind, placebo-controlled trial featuring 682 patients who have early stage non-small cell lung cancer and EGFR exon 19 deletions or exon 21 L858R mutation-positive who underwent complete tumor removal.
In the trial, 339 patients were subjected to Tagrisso orally once daily and 343 were given a placebo after recovery from surgery and standard adjuvant chemotherapy, if given.
The main outcome measure was the time it took for cancer to recur or for death to happen from any cause, which is disease-free survival.
In the overall trial population, patients in the Tagrisso arm saw an 80% reduction in the chance of disease recurrence in comparison to those in the placebo arm.
AstraZeneca bagged Tagrisso FDA approval in 2018 for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.