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Tagrisso Approval History

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has worsened on or after EGFR-TKI therapy.

FDA Approval: The approval of Tagrisso is based on data from the two AURA Phase II studies (AURA extension and AURA2) involving a total of 411 patients with advanced EGFR T790M mutation-positive NSCLC whose disease had progressed after treatment with an EGFR inhibitor. In these two studies, 57 percent of patients in the first study and 61 percent of patients in the second study experienced a complete or partial reduction in their tumor size. The FDA has also approved the companion diagnostic cobasĀ® EGFR Mutation Test v2 to detect EGFR mutations in patients with non-small cell lung cancer, including T790M.

Mechanism: The EGFR gene is a protein involved in the growth and spread of cancer cells. EGFR tyrosine kinase inhibitors (EGFR-TKIs) are targeted treatments for non-small cell lung cancer, but tend to develop resistance over time, often as the result of EGFR mutations. Tagrisso is an EGFR-TKI that works against cells with the T790M mutation, one of the primary causes of EGFR resistance.

Administration: Tagrisso tablets are taken orally once daily, with or without food.

Side Effects: The most common side effects of Tagrisso include diarrhea, and skin and nail conditions such as dry skin, rash and infection or redness around the fingernails. Tagrisso may cause serious side effects including interstitial lung disease (ILD)/pneumonitis, QTc interval prolongation and cardiomyopathy.

Additional Information: Tagrisso may harm a developing fetus and females of reproductive potential are advised to use effective contraception during treatment and for six weeks after the final dose. Males with female partners of reproductive potential are advised to use effective contraception during treatment and for four months after the final dose.

Development History and FDA Approval Process for Tagrisso

DateArticle
Nov 13, 2015Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer
Apr 17, 2015AstraZeneca announces updated progression free survival data for investigational non-small cell lung cancer medicine AZD9291

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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