Tagrisso (osimertinib) is a treatment for certain non-small cell lung cancer patients approved by the U.S. Food and Drug Administration (FDA) and marketed by AstraZeneca. Tagrisso is taken once daily as an oral tablet.
How Tagrisso works
It is a tyrosine-kinase inhibitor (TKI), meaning it works by inhibiting a type of enzyme (called tyrosine kinases) that is involved in cell signaling. Tyrosine kinases can stimulate cell division and they are unusually active in many cancers, which results in the uncontrolled growth of cells.
In non-small cell lung cancer (NSCLC), many tumor cells have mutations in a tyrosine kinase called the epidermal growth factor receptor (EGFR, sometimes referred to as HER-1) that can cause cell proliferation and continued tumor growth. Tagrisso specifically and irreversibly inhibits EGFR from triggering cell division.
History of Tagrisso
Tagrisso is approved as a treatment for patients with NSCLC who have a particular mutation — known as T790M — in the EGFR gene.
On March 31, 2017 received full approval by the FDA as a second-line treatment in people whose disease has progressed following TKI therapy. To be eligible for treatment with Tagrisso, the tumor must have tested positive for the EGFR T790M mutation, by an FDA-approved test.
It was also fully approved for marketing in the EU by the European Commission (EC) on April 25, 2017. Tagrisso also received full approval in Japan, and is approved under the Priority Review pathway in China. Patients with EGFR T790M-positive NSCLC tumors in Europe, Japan, and China are eligible for this treatment whether or not they have completed a previous TKI therapy.
The drug’s approval was largely based on the results of a randomized, open-label Phase 3 clinical trial (AURA3, NCT02151981). This trial compared the efficacy of Tagrisso to standard platinum-based chemotherapy in advanced EGFR T790M-positive NSCLC patients who have become resistant to previous TKI therapies. Patients treated with Tagrisso displayed a significantly improved progression-free survival compared to platinum-based chemotherapy (at 10.1 months compared to 4.4 months). The study’s full results were published in the New England Journal of Medicine. The most common adverse reactions observed throughout the AURA3 trial were diarrhea, rashes, dry skin, nail toxicity, and fatigue. Patients who were given Tagrisso had a lower proportion of severe (grade 3 or higher) adverse effects than those given platinum-based chemotherapy (23 percent compared to 47 percent).
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