Tagrisso

Treats locally advanced, unresectable (stage III) NSCLC. NDA 208065, held by Astrazeneca. Osimertinib Mesylate.

As of Nov 13, 2026, NDA 208065 (Tagrisso), held by Astrazeneca, was first approved by FDA on Nov 13, 2015, with 24 approved supplements and 0 published complete response letters.

First approved: Nov 13, 2015
Review: Priority
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TAGRISSO is a kinase inhibitor indicated for:

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. ( 1.1, 2.2 )
the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.2, 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below


Sep 14, 2026	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 25, 2024	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 16, 2024	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 31, 2024	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 18, 2020	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 9, 2020	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 18, 2018	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 30, 2017	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 13, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


TagrissoEQ 40MG BASE · tablet;oral	Osimertinib Mesylate	RxReference drug
TagrissoEQ 80MG BASE · tablet;oral	Osimertinib Mesylate	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Sep 14, 2026	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 14, 2026	Supplement 36Labeling · Standard review	Approved	Label Letter
Sep 25, 2024	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 29, 2024	Supplement 31Labeling · Standard review	Approved	Letter Label
Feb 16, 2024	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 31, 2024	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 21, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 21, 2022	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 30, 2022	Supplement 26Labeling · Standard review	Approved	Letter Label
Jan 19, 2022	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 26, 2021	Supplement 22Labeling · Standard review	Approved	Label Letter
Dec 18, 2020	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 11, 2020	Supplement 19Labeling · Standard review	Approved	Letter Label
Dec 9, 2020	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 23, 2020	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 19, 2019	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 28, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Apr 18, 2018	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 18, 2018	Supplement 9Labeling · Standard review	Approved	Letter
Oct 31, 2017	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 30, 2017	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 28, 2016	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 12, 2016	Supplement 2Labeling · Standard review	Approved	Label Letter
Feb 10, 2016	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 13, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 208065
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters