TriangleLABELS · d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
TAGRISSO
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2024-09-25
- Captured
- 2026-09-09T23:38:02.384588+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source text
- 1 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 , 2.2 ) • 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. ( 1.3 , 2.2 ) • in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.4 , 2.2 ) • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. ( 1.5 , 2.2 ) 1.1 Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) TAGRISSO is 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 [see Dosage and Administration (2.2) ] . 1.2 Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC TAGRISSO is indicated for 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 [see Dosage and Administration (2.2)]. 1.3 First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC TAGRISSO is indicated 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 [see Dosage and Administration (2.2) ]. 1.4 First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC TAGRISSO in combination with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ]. 1.5 Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy [see Dosage and Administration (2.2) ] .
Full extracted label fields
- application numbers
- NDA208065
- boxed warning exact
- brand names
- TAGRISSO
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7
- generic names
- OSIMERTINIB
- id
- d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
- indications and usage exact
- 1 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 , 2.2 ) • 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. ( 1.3 , 2.2 ) • in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.4 , 2.2 ) • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. ( 1.5 , 2.2 ) 1.1 Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) TAGRISSO is 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 [see Dosage and Administration (2.2) ] . 1.2 Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC TAGRISSO is indicated for 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 [see Dosage and Administration (2.2)]. 1.3 First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC TAGRISSO is indicated 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 [see Dosage and Administration (2.2) ]. 1.4 First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC TAGRISSO in combination with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ]. 1.5 Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy [see Dosage and Administration (2.2) ] .
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- AstraZeneca Pharmaceuticals LP
- matched search terms
- cancer
- tumor
- tumors
- package ndcs
- 0310-1349-30
- 0310-1350-30
- 0310-1350-95
- 0310-1350-99
- 0310-1248-30
- 0310-1251-30
- product ndcs
- 0310-1248
- 0310-1349
- 0310-1350
- 0310-1251
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- Indications and Usage ( 1.2 ) 09/2024 Indications and Usage ( 1.4 ) 02/2024 Dosage and Administration, Patient Selection ( 2.2 ) 09/2024 Dosage and Administration, Recommended Dosage and Administration ( 2.3 ) 09/2024 Dosage and Administration, Dosage Modifications ( 2.5 ) 09/2024 Warnings and Precautions, Interstitial Lung Disease/Pneumonitis ( 5.1 ) 09/2024 Warnings and Precautions, QTc Interval Prolongation ( 5.2 ) 09/2024 Warnings and Precautions, Cardiomyopathy ( 5.3 ) 09/2024 Warnings and Precautions, Keratitis ( 5.4 ) 09/2024 Warnings and Precautions, Aplastic Anemia ( 5.7 ) 02/2024
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 1721565
- 1721571
- 1721581
- 1721583
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00700.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 700
- total
- 830
- sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22d703b5ed-4b1c-44fe-8005-ebe3d8f563e6%22
- spl effective date
- 2024-09-25
- spl effective time
- 20240925
- spl set id
- 5e81b4a7-b971-45e1-9c31-29cea8c87ce7
- spl version
- 36
- substance names
- OSIMERTINIB
- uniis
- 3C06JJ0Z2O
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
- fda_label_posted_after_spl_effective_date_requires_version_review
Drugs@FDA application source records
- application number
- NDA208065
- payload
- all indexed label documents
- Appl No
- 208065
- Application Docs Date
- 2015-11-13 00:00:00
- Application Docs ID
- 19981
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 208065
- Application Docs Date
- 2016-08-17 00:00:00
- Application Docs ID
- 45077
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2017-02-22 00:00:00
- Application Docs ID
- 47283
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf
- Submission No
- 3
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2017-03-30 00:00:00
- Application Docs ID
- 47794
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s006lbl.pdf
- Submission No
- 6
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2017-10-31 00:00:00
- Application Docs ID
- 50246
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208065s007lbl.pdf
- Submission No
- 7
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2018-04-19 00:00:00
- Application Docs ID
- 53732
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2018-08-29 00:00:00
- Application Docs ID
- 55351
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208065s011lbl.pdf
- Submission No
- 11
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2019-12-23 00:00:00
- Application Docs ID
- 61425
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208065s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2020-06-02 00:00:00
- Application Docs ID
- 63400
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s016lbl.pdf
- Submission No
- 16
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2020-12-10 00:00:00
- Application Docs ID
- 65555
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s018lbl.pdf
- Submission No
- 18
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2020-12-14 00:00:00
- Application Docs ID
- 65582
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s019lbl.pdf
- Submission No
- 19
- Submission Type
- SUPPL
- Appl No
- 208065
- Application Docs Date
- 2020-12-18 00:00:00
- Application Docs ID
- 65624
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf
- Submission No
- 21
- Submission Type
- SUPPL
- all submission records
- Appl No
- 208065
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 33
- Submission Status
- AP
- Submission Status Date
- 2024-09-25 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 31
- Submission Status
- AP
- Submission Status Date
- 2024-04-29 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 30
- Submission Status
- AP
- Submission Status Date
- 2024-02-16 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 29
- Submission Status
- AP
- Submission Status Date
- 2024-01-31 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 28
- Submission Status
- AP
- Submission Status Date
- 2023-06-21 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 27
- Submission Status
- AP
- Submission Status Date
- 2022-10-21 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 26
- Submission Status
- AP
- Submission Status Date
- 2022-09-30 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 25
- Submission Status
- AP
- Submission Status Date
- 2022-01-19 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 22
- Submission Status
- AP
- Submission Status Date
- 2021-07-26 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 21
- Submission Status
- AP
- Submission Status Date
- 2020-12-18 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 19
- Submission Status
- AP
- Submission Status Date
- 2020-12-11 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208065
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 18
- Submission Status
- AP
- Submission Status Date
- 2020-12-09 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- application number
- NDA208065
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208065
- has approved submission record
- true
- latest approved submission date
- 2024-09-25
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 208065
- Application Docs Date
- 2024-09-26 00:00:00
- Application Docs ID
- 79737
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf
- Submission No
- 33
- Submission Type
- SUPPL
- official application record
- Appl No
- 208065
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- ASTRAZENECA
- openfda application present
- true
- products
- Active Ingredient
- OSIMERTINIB MESYLATE
- Appl No
- 208065
- Drug Name
- TAGRISSO
- Form
- TABLET;ORAL
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 40MG BASE
- marketing status
- Prescription
- Active Ingredient
- OSIMERTINIB MESYLATE
- Appl No
- 208065
- Drug Name
- TAGRISSO
- Form
- TABLET;ORAL
- Product No
- 002
- Reference Drug
- 1
- Reference Standard
- 1
- Strength
- EQ 80MG BASE
- marketing status
- Prescription
Source passages and status connections
Passage 1 · indication intro context
- application numbers
- NDA208065
- brand names
- TAGRISSO
- classification reasons
- explicit_positive_indication_predicate
- no_tumor_directed_keyword_in_positive_statement
- incomplete_colon_led_indication_intro
- clinical review status
- pending
- content role
- indication_intro_context
- context span
- end
- 269
- end exclusive
- true
- exact text
- 1 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 mutatio
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- offset unit
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- 0
- source field
- indications_and_usage_exact
- source text sha256
- 9efb088d72ee29ed5898553d2db0589d4daf58a3fd13f04eb846a649a043d567
- start
- 0
- current approval status
- not_reconciled
- duplicate text group
- dup-336564d233d23f6378cb
- extraction review status
- automated_candidate_pending_source_review
- generic names
- OSIMERTINIB
- id
- ind-span-8a0e2d288ff037580155
- label id
- d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
- positive predicate support span
- end
- 64
- end exclusive
- true
- exact text
- is a kinase inhibitor indicated
- label id
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- offset unit
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- source field
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- source text sha256
- 9efb088d72ee29ed5898553d2db0589d4daf58a3fd13f04eb846a649a043d567
- start
- 33
- qualifier mentions
- regulatory links
- schema version
- 0.1.0
- source batch sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source defined aliases
- abbreviation
- NSCLC
- definition exact
- non-small cell lung cancer
- definition span
- end
- 168
- end exclusive
- true
- exact text
- non-small cell lung cancer (NSCLC)
- label id
- d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
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- source field
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- source text sha256
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- start
- 134
- source span
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- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE TAGRISSO is a kinase inhibitor indicated for:
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- offset unit
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- source text sha256
- 9efb088d72ee29ed5898553d2db0589d4daf58a3fd13f04eb846a649a043d567
- start
- 0
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22d703b5ed-4b1c-44fe-8005-ebe3d8f563e6%22
- spl effective date
- 2024-09-25
- spl set id
- 5e81b4a7-b971-45e1-9c31-29cea8c87ce7
- spl version
- 36
- structured fields status
- not_extracted_no_values_inferred_from_mentions
- structured indication
- age
- Source null
- approval pathway
- Source null
- biomarker and test
- Source null
- disease stage
- Source null
- limitations
- Source null
- line
- Source null
- prior therapy
- Source null
- regimen
- Source null
- tumor histology
- Source null
- use intent
- not_applicable
Passage 2 · positive indication candidate
- application numbers
- NDA208065
- brand names
- TAGRISSO
- classification reasons
- inherited_predicate_from_same_label_section_requires_review
- tumor_or_malignant_hematology_words_in_positive_statement
- clinical review status
- pending
- content role
- positive_indication_candidate
- context span
- end
- 509
- end exclusive
- true
- exact text
- 1 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 chem
- label id
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- offset unit
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- source field
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- source text sha256
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- start
- 0
- current approval status
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- duplicate text group
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- generic names
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- id
- ind-span-b4b028f506905c566187
- label id
- d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
- positive predicate support span
- end
- 64
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- exact text
- is a kinase inhibitor indicated
- label id
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- offset unit
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- source text sha256
- 9efb088d72ee29ed5898553d2db0589d4daf58a3fd13f04eb846a649a043d567
- start
- 33
- qualifier mentions
- context exact
- • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have e
- kind
- age
- polarity
- not_inferred
- span
- end
- 128
- end exclusive
- true
- exact text
- adult patients
- label id
- d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
- offset unit
- unicode_code_points
- source array index
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- source field
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- source text sha256
- 9efb088d72ee29ed5898553d2db0589d4daf58a3fd13f04eb846a649a043d567
- start
- 114
- context exact
- (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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Preserved source evidence · Not medical advice