Neratinib
Also known as Nerlynx, Neratinib maleate
PUMA BIOTECHNOLOGY, INC. PBYI · Breast Cancer; HER2+ Metastatic Breast Cancer (MBC)
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
NDA208051,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- PUMA BIOTECHNOLOGY, INC. PBYI Source: Company record for PUMA BIOTECHNOLOGY, INC. (opens in a new tab)
- Indications
- Breast Cancer; HER2+ Metastatic Breast Cancer (MBC) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 208051 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208051 (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 9 Jul 20092 linked trials
- Filed Completed
- Approved Current stageFirst approval 17 Jul 2017
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 Neratinib. Editors add each one with its source.
Filed application
No filed application is on record for Neratinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Neratinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT01808573ClinicalTrials.gov record for NCT01808573 (opens in a new tab)NALA | A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting | Phase 3 | Completed | 621 (actual) | 28 Sep 2018 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01808573 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NALA
Serious adverse events (From time of first dose, through 28 days after last dose, assessed up to 41 months.): Neratinib Plus Capecitabine 103 of 303; Lapatinib Plus Capecitabine 93 of 311 Source: ClinicalTrials.gov results for NCT01808573 (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 NALA (2), 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. | ||||||
| NCT00878709ClinicalTrials.gov record for NCT00878709 (opens in a new tab)ExteNET | Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | Phase 3 | Completed | 2,840 (actual) | 21 Aug 2014 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT00878709 (opens in a new tab) |
Posted results on ClinicalTrials.gov for ExteNET
Serious adverse events (From first dose through 28 days after the last dose, up to two years.): Neratinib 103 of 1408; Placebo 85 of 1408 Source: ClinicalTrials.gov results for NCT00878709 (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 ExteNET (7), newest first
All 7 publications for NCT00878709 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
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA208051Action letter for NDA208051 (opens in a new tab) | Supplement 9 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208051Action letter for NDA208051 (opens in a new tab) | Supplement 7 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208051Action letter for NDA208051 (opens in a new tab) | Supplement 5 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208051Action letter for NDA208051 (opens in a new tab) | Supplement 6 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208051Action letter for NDA208051 (opens in a new tab) | Supplement 4 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208051Action letter for NDA208051 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
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
Nerlynx (EMEA/H/C/004030)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Pierre Fabre Medicament
- Active substance (INN)
- neratinib
- ATC code
- L01EH02
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Nerlynx (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 208051 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT01808573 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT00878709 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA208051 (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.