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Tagrisso approved as first-line treatment for metastatic NSCLC

The US Food and Drug Administration (FDA) has approved the protein kinase inhibitor Tagrisso (osimertinib) as a first-line treatment option for certain patients with metastatic non-small cell lung carcinoma (NSCLC). Earlier this month, AstraZeneca presented new data from a Phase III FLAURA trial demonstrating the progression-free survival benefits of first-line treatment with Tagrisso.

Tagrisso is already indicated as a second line treatment for certain patients with lung cancer whose tumor has a specific genetic marker. The FDA granted Tagrisso Breakthrough Therapy and Priority Review status in the in first-line treatment setting in 2017. It works by inhibiting the growth and spread of cancer cells in the body by binding to a certain protein, the epidermal growth factor receptor (EGFR), in these tumors. The benefits of the drug in an adjuvant setting and in combination with other treatments are also being investigated. 

The latest FLAURA trial compared the efficacy of current first-line treatment with erlotinib or gefitinib with Tagrisso in previously untreated patients with locally advanced or metastatic EGFR-mutated NSCLC. Median progression-free survival among Tagrisso patients was 18.9 months, compared to 10.2 months in the patients treated with the other two cancer medicines. 

Common Adverse Reactions to Tagrisso:

  • Diarrhea
  • Rash
  • Dry Skin
  • Nail toxicity
  • Stomatitis
  • Fatigue
  • Decreased appetite

Commenting on the latest approval, Suresh S Ramalingam, MD, of the Winship Cancer Institute of Emory University, Atlanta and principal investigator of the FLAURA trial, described the FDA decision as a “major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm”. 

“Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors,” he added. 

More Americans die from lung cancer than any other form of cancer, according to data from the Centers for Disease Control and Prevention (CDC). NCSLC is the most common variety of lung cancer, accounting for around 85 percent of cases and approximately one in five cancer deaths. 

In February 2018, the FDA approved AstraZeneca drug Imfinzi (durvalumab) as a treatment for patients with stage III NSCLC who have unresectable tumors (tumors that cannot be removed surgically) whose cancer has not progressed following chemotherapy and radiation. The antineoplastic monoclonal antibody works by blocking the interactions between proteins on the body’s immune cells and certain cancer cells, which helps the immune system attack the cancer cells.