Tagrisso FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 22, 2020.

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:

• as adjuvant therapy after tumor resection in adult patients with non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
• for the treatment of adult patients with metastatic EGFR T790M mutationpositive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

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

Development timeline for Tagrisso

Date	Article
Dec 21, 2020	Approval Tagrisso Approved in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer
Apr 18, 2018	Approval FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer
Jun  6, 2017	AstraZeneca Presents Tagrisso (osimertinib) Data in Patients with EGFR T790M-Mutation Positive Lung Cancer and Central Nervous System Metastases
Mar 31, 2017	Approval Tagrisso (osimertinib) Receives FDA Full Approval
Nov 13, 2015	Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer