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Tagrisso FDA Approval History

Reviewed by J.Stewart B.Pharm. Last updated on Apr 18, 2018.

FDA Approved: Yes (First approved November 13, 2015)
Brand name: Tagrisso
Generic name: osimertinib
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Non-Small Cell Lung Cancer

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.

FDA Approval:The accelerated approval of Tagrisso in 2015 was 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.

Full approval was granted March 2017 based on data from the randomised, Phase III AURA3 trial, in which Tagrisso significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median PFS compared to 4.4 months from chemotherapy.

In April 2018, Tagrisso received approval as a first line treatment for EGFR-mutated non-small cell lung cancer.

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 Timeline for Tagrisso

Apr 18, 2018Approval FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer
Mar 31, 2017Approval Tagrisso (osimertinib) Receives FDA Full Approval
Nov 13, 2015Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Further information

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