FDA approves first adjuvant therapy for most common type of lung cancer

Dec. 21, 2020

The U.S. Food and Drug Administration (FDA) approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation. 

Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide. In the U.S., approximately 229,000 adults will be diagnosed with lung cancer in 2020, of which 76 percent of cases will be non-small cell lung cancer. Approximately 20 percent of patients with non-small cell lung cancer will have epidermal growth factor receptor (EGFR) mutations, which are mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. 

Although most patients who are diagnosed with non-small cell lung cancer have unremovable tumors, 30 percent have resectable disease; thus, more than 10,000 patients nationwide each year may be candidates for Tagrisso as adjuvant therapy after tumor removal. Tagrisso was approved in 2018 for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. 

In the overall trial population, patients who received Tagrisso had an 80 percent decrease in chance of disease recurrence compared with patients who received a placebo.  

Tagrisso received Orphan Drug designation for treatment of EGFR mutation-positive non-small cell lung cancer. Orphan Drug designation provides incentives to assist and encourage drug development for rare diseases. Additionally, the agency granted Tagrisso a Breakthrough Therapy designation for this indication. 

The FDA granted the approval of Tagrisso to AstraZeneca. 

FDA has the release

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