Palbociclib
Also known as Ibrance
PFIZER INC PFE · Breast Cancer; Advanced Breast Cancer Female; Breast Neoplasms; Metastatic Breast Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
5
From ClinicalTrials.gov
Latest FDA action
Approved
NDA207103,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- PFIZER INC PFE Source: Company record for PFIZER INC (opens in a new tab)
- Indications
- Breast Cancer; Advanced Breast Cancer Female; Breast Neoplasms; Metastatic Breast Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 207103 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 207103 (opens in a new tab)
- NDA 212436 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 212436 (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 26 Sep 20135 linked trials
- Filed Completed
- Approved Current stageFirst approval 3 Feb 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 Palbociclib. Editors add each one with its source.
Filed application
No filed application is on record for Palbociclib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Palbociclib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06760637ClinicalTrials.gov record for NCT06760637 (opens in a new tab)FourLight-3 | Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease | Phase 3 | Active, not recruiting | 1,035 (actual) | 2 Jan 2029 (estimated) | No |
| NCT05909397ClinicalTrials.gov record for NCT05909397 (opens in a new tab)VERITAC-3 | Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | Phase 3 | Active, not recruiting | 59 (actual) | 30 Dec 2026 (estimated) | No |
| NCT02600923ClinicalTrials.gov record for NCT02600923 (opens in a new tab) | Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate | Phase 3 | Completed | 131 (actual) | 28 May 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02600923 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT02600923 Serious adverse events (3 years): Palbociclib+Letrozole 32 of 130 Source: ClinicalTrials.gov results for NCT02600923 (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 NCT02600923 (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. | ||||||
| NCT02297438ClinicalTrials.gov record for NCT02297438 (opens in a new tab) | A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] | Phase 3 | Completed | 340 (actual) | 31 Aug 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02297438 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT02297438
Serious adverse events (Up to 28 days after last dose of study drug or start of new treatment (data collection maximum up to approximately 119 months after randomization)): Palbociclib + Letrozole 34 of 168; Placebo + Letrozole 19 of 171 Source: ClinicalTrials.gov results for NCT02297438 (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 NCT02297438 (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. | ||||||
| NCT01942135ClinicalTrials.gov record for NCT01942135 (opens in a new tab) | Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) | Phase 3 | Completed | 521 (actual) | 5 Dec 2014 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01942135 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT01942135
Serious adverse events (From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).): Palbociclib + Fulvestrant 78 of 345; Placebo + Fulvestrant 33 of 172 Source: ClinicalTrials.gov results for NCT01942135 (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 NCT01942135 (23), newest first
All 23 publications for NCT01942135 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
Ibrance (EMEA/H/C/003853)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Active substance (INN)
- palbociclib
- ATC code
- L01EF01
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name. EMA lists 1 other product with this substance, such as generics.
EMA page for Ibrance (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 207103 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06760637 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05909397 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02600923 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02297438 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT01942135 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA207103 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA212436 (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.