FDA Approves Osimertinib for Metastatic EGFR T790M Mutation-Positive NSCLC

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The FDA has granted accelerated approval to osimertinib (Tagrisso) for the treatment of non-small cell lung cancer.
The FDA has granted accelerated approval to osimertinib (Tagrisso) for the treatment of non-small cell lung cancer.

The U.S. Food and Drug Administration has granted accelerated approval to osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) after progression on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

Approval was based on 2 multicenter, single-arm, open-label clinical trials that included a total of 411 patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI.

Results showed that 57% of patients in study 1 and 61% of patients in study 2 achieved an objective response, with 96% of patients having ongoing responses at the time of primary analysis.

In regard to safety, the most common adverse events were diarrhea, rash, dry skin, nail toxicity, eye disorders, nausea, decreased appetite, and constipation, with the majority being grade 1 or 2. The most common grade 3 to 4 adverse events were pneumonia and pulmonary embolism.

Health care providers should be aware that osimertinib can cause interstitial lung disease/pneumonitis, QTc interval prolongation, cardiomyopathy, and embryo-fetal toxicity.

Females should be advised of the potential risk to the fetus and to use effective contraception during treatment with osimertinib and for 6 weeks after the final dose. Males should use effective contraception for 4 months after the last dose.

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Drug interactions may also occur between strong CYP3A4 inhibitors and inducers and osimertinib. Clinicians should avoid concurrent administration with osimertinib if possible.

The recommended dose and schedule of osimertinib is 80 mg tablet once daily with or without food until disease progression or unacceptable toxicity. Patients who have difficulty swallowing can disperse tablets in 4 tablespoons of water.

The presence of a T790M EGFR mutation should be confirmed prior to initiation of osimertinib with an FDA-approved diagnostic test.


  1. Osimertinib [news release]. U.S. Food and Drug Administration. November 13, 2015. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472565.htm. Accessed November 13, 2015.

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