Osimertinib
Also known as Tagrisso, Osimertinib mesylate
ASTRAZENECA PLC AZN · Non-small Cell Lung Cancer; Anticancer Treatment; Cancer; Carcinoma; Carcinoma, Non-Small-Cell Lung
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
11
From ClinicalTrials.gov
Latest FDA action
Approved
NDA208065,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Non-small Cell Lung Cancer; Anticancer Treatment; Cancer; Carcinoma; Carcinoma, Non-Small-Cell Lung Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 208065 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208065 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 4 Aug 201411 linked trials
- Filed Completed
- Approved Current stageFirst approval 13 Nov 2015
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Osimertinib. Editors add each one with its source.
Filed application
No filed application is on record for Osimertinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Osimertinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06417814ClinicalTrials.gov record for NCT06417814 (opens in a new tab)TROPION-Lung15 | A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Phase 3 | Active, not recruiting | 768 (actual) | 11 Jan 2027 (estimated) | No |
Publications listing TROPION-Lung15 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06350097ClinicalTrials.gov record for NCT06350097 (opens in a new tab)TROPION-Lung14 | Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer | Phase 3 | Recruiting | 582 (estimated) | 21 Mar 2028 (estimated) | No |
Publications listing TROPION-Lung14 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT05629234ClinicalTrials.gov record for NCT05629234 (opens in a new tab)ROSY-T | Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T) | Phase 3 | Active, not recruiting | 37 (estimated) | 22 Feb 2027 (estimated) | No |
| NCT05261399ClinicalTrials.gov record for NCT05261399 (opens in a new tab)SAFFRON | Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment | Phase 3 | Active, not recruiting | 341 (actual) | 6 Jul 2026 (actual) | No |
| NCT05120349ClinicalTrials.gov record for NCT05120349 (opens in a new tab)ADAURA2 | A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection | Phase 3 | Active, not recruiting | 390 (actual) | 2 Aug 2027 (estimated) | No |
Publications listing ADAURA2 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04765059ClinicalTrials.gov record for NCT04765059 (opens in a new tab)COMPEL | A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Active, not recruiting | 98 (actual) | 28 Oct 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04765059 (opens in a new tab) |
Posted results on ClinicalTrials.gov for COMPEL
Serious adverse events (From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)): Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin 18 of 48; Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin 15 of 48 Source: ClinicalTrials.gov results for NCT04765059 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT04351555ClinicalTrials.gov record for NCT04351555 (opens in a new tab)NeoADAURA | A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer | Phase 3 | Active, not recruiting | 358 (actual) | 15 Oct 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04351555 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NeoADAURA
Serious adverse events (Includes adverse events during the neoadjuvant analysis period, defined as from the first dose to the minimum of (date of last dose in neoadjuvant period + 28 days, the next treatment start date - 1, date of withdrawal of consent, date of death). For participants who received Osimertinib or Placebo, this was up to 138 days. For participants who received Pemetrexed, Cisplatin or Carboplatin, this was up to 107 days.): Osimertinib + Chemo 24 of 119; Osimertinib 13 of 117; Placebo + Chemo 24 of 120 Source: ClinicalTrials.gov results for NCT04351555 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NeoADAURA (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04035486ClinicalTrials.gov record for NCT04035486 (opens in a new tab)FLAURA2 | A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) | Phase 3 | Active, not recruiting | 587 (actual) | 3 Apr 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04035486 (opens in a new tab) |
Posted results on ClinicalTrials.gov for FLAURA2
Serious adverse events (Includes treatment emergent adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy. For the Safety Run-In treatment arms, this was up to 45 months, or the data cut-off. For the Randomized treatment arms, this was up to 33 months, or the data cut-off.): Safety Run-In: AZD9291 + Carboplatin + Pemetrexed 5 of 15; Safety Run-In: AZD9291 + Cisplatin + Pemetrexed 6 of 15; Randomized: AZD9291 + Chemo 104 of 276; Randomized: AZD9291 53 of 275 Source: ClinicalTrials.gov results for NCT04035486 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing FLAURA2 (9), newest first
All 9 publications for NCT04035486 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03833154ClinicalTrials.gov record for NCT03833154 (opens in a new tab)PACIFIC-4 | Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation | Phase 3 | Active, not recruiting | 724 (actual) | 31 Oct 2028 (estimated) | No |
| NCT03521154ClinicalTrials.gov record for NCT03521154 (opens in a new tab)LAURA | A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) | Phase 3 | Active, not recruiting | 216 (actual) | 5 Jan 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03521154 (opens in a new tab) |
Posted results on ClinicalTrials.gov for LAURA
Serious adverse events (From the time of signature of informed consent throughout the treatment period (maximum actual duration of 62.4 and 56.2 months for Osimertinib and Placebo respectively) up to and including 28 day follow up following last dose of study drug.): Osimertinib 55 of 143; Placebo 11 of 73 Source: ClinicalTrials.gov results for NCT03521154 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing LAURA (8), newest first
All 8 publications for NCT03521154 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT02151981ClinicalTrials.gov record for NCT02151981 (opens in a new tab)AURA3 | AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Phase 3 | Completed | 421 (actual) | 15 Apr 2016 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02151981 (opens in a new tab) |
Posted results on ClinicalTrials.gov for AURA3
Serious adverse events (AEs from start of study drug until 28 days post treatment discontinuation up to 4 years and 7 months (at the time of analysis)): Osimertinib 80 mg 84 of 279; Chemotherapy 36 of 136 Source: ClinicalTrials.gov results for NCT02151981 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing AURA3 (13), newest first
All 13 publications for NCT02151981 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Tagrisso (EMEA/H/C/004124)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- osimertinib
- ATC code
- L01XE
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Tagrisso (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 208065 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06417814 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06350097 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05629234 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05261399 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05120349 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04765059 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04351555 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04035486 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03833154 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03521154 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02151981 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA208065 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.