Drug · Small Molecule

Palbociclib

CI-DRUG-00000447Explore in graph →NCIt C49176 CHEMBL189963 CIViC Approved

Regulatory

Approvals (40)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory40 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552140) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 27, 2024	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	103	40	29	256	40	CA, EU, US	Feb 3, 2015	2004-09
Malignant Breast Neoplasm	Approved	Phase 4	42	12	11	113	8	EU, US	Feb 3, 2015	Sep 15, 2008
Malignant Ovarian Neoplasm	Phase4	Phase 4	8	5	0	13	0	—	—	Aug 17, 2015
Malignant Kidney Neoplasm	Phase4	Phase 4	3	1	0	7	0

Curated evidence

Clinical evidence (92)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 92 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FLT3 E588_Y589INSKYFYVDFRE1
Palbociclib

Clinical trials

Trials with this intervention (283)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 283 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04711252	A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease(SERENA-4)	active not recruiting	Phase 3	1,371	AstraZenecaINDUSTRY	27	Sep 28, 2026	clinicaltrials
NCT05564377	Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Molecule

Record

Kind: Small Molecule
Mechanism: CDK6/cyclin D1 inhibitor; Cyclin-dependent kinase 4/cyclin D1 inhibitor
Targets: 3 genes
UNII: G9ZF61LE7G
Aliases: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, IBRANCE, NAT-PALBOCICLIB, Palbociclib, PALBOCICLIB ISETHIONATE, PALBOCICLIBPD-0332991PD0332991IBRANCECS-0019A-1030, Palbociclib Viatris, PD 0332991, PD-0332991, PD0332991, PD-03329910054, PD 332991, PD 991, PF-0008066573, PFE-PKIS 32, PMS-PALBOCICLIB, Pyrido(2,3-d)pyrimidin-7(8H)-one, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-, TARO-PALBOCICLIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (33)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EF01	PALBOCICLIB
DIN (Health Canada)	02453150

CDKN2A Loss5
Palbociclib	Cutaneous MelanomaALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1375 In a cohort of 143 patients with primary invasive melanoma hemizygous or homozygous loss of CDKN2A was observed (FISH) in 56% of cases. PD0332991 efficacy (proliferation assay) was assessed in a panel… (full text at CIViC) PMID 24495407 · Young et al., 2014 · Open in CIViC	civic
〃	Dermatofibrosarcoma Protuberans	Predictive	D	Supports Sensitivity Response	2	accepted	EID1881 An imatinib-resistant cell line, DFSP105, was established from a dermatofibrosarcoma protuberans which had progressed to a high-grade fibrosarcomatous DFSP. The disease-associated COL1A1-PDGFB fusion … (full text at CIViC) PMID 25852058 · Eilers et al., 2015 · Open in CIViC	civic
Linsitinib + PalbociclibSubstitutes	Ewing Sarcoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID1879 A patient-derived xenograft (PDX) from a patient with cyclin-dependent kinase inhibitor 2A/B (CDKN2A/B) loss and FUS-ERG fusion positive Ewing's sarcoma was created. The PDX was treated in four cohort… (full text at CIViC) PMID 27286459 · Murakami et al., 2016 · Open in CIViC	civic
Palbociclib	GlioblastomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	submitted	EID1559 Short term explant cultures from 20 glioblastoma multiforme (GBM) tumor xenograft lines were evaluated for CDKN2A (p16 aka INK4A) expression by western blot and RT-PCR as well as deletion by aCGH and … (full text at CIViC) PMID 22711607 · Cen et al., 2012 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Resistance	2	accepted	EID7444 TAPUR, a phase II basket trial, included a cohort of patients with advanced non-small lung cell carcinoma (NSCLC) harboring with CDKN2A loss or mutation and no RB mutations. Twenty-nine patients were … (full text at CIViC) Open in CIViC	civic

CDK4 Amplification2
Palbociclib	Liposarcoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID1366 In a phase 2 clinical trial, NCT01209598, 30 patients with CDK4-amplified and RB-expressing well differentiated and dedifferentiated liposarcomas (WDLS/DDLS) were treated with a selective CDK 4/6 inhi… (full text at CIViC) PMID 23569312 · Dickson et al., 2013 · Open in CIViC	civic
〃	Liposarcoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID4841 A total of 59 patients with well-differentiated or dedifferentiated liposarcomas were enrolled in a phase 2 study to evaluate palbociclib efficacy. Half of the patients had received prior treatment an… (full text at CIViC) PMID 27124835 · Dickson et al., 2016 · Open in CIViC	civic

CCND1 Amplification2
Palbociclib	Lung Squamous Cell Carcinoma	Predictive	B	Does Not Support Sensitivity Response	4	submitted	EID7405 In a phase II trial, patients with squamous non-small cell lung cancer who had progressed at least one prior platinum-based chemotherapy with CCND1/2/3 or CDK 4 amplification were treated with palboci… (full text at CIViC) PMID 31302234 · Edelman et al., 2019 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	2	accepted	EID1562 A panel of 47 breast cancer cell lines was tested for sensitivty/resistance to CDK4/6 inhibitor Palbociclib (PD0332991), where IC50 below 150nM was sensitive, and above 1000nM resistant. Cyclin D1 ha… (full text at CIViC) PMID 19874578 · Finn et al., 2009 · Open in CIViC	civic

CCNE1 Overexpression2
Palbociclib	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	submitted	EID10182 Breast cancer cell lines derived from T-47D (vector control, overexpress cyclin E1, overexpress cyclin E2) were treated with CDK4/6 inhibitor PD0332991 and CDK2 inhibitor SNS-032 as single agents and … (full text at CIViC) PMID 22564725 · Caldon et al., 2012 · Open in CIViC	civic
CDK Inhibitor SNS-032 + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID10183 Breast cancer cell lines derived from T-47D (vector control, overexpress cyclin E1, overexpress cyclin E2) were treated with CDK4/6 inhibitor PD0332991 and CDK2 inhibitor SNS-032 as single agents and … (full text at CIViC) PMID 22564725 · Caldon et al., 2012 · Open in CIViC	civic

CCNE2 Overexpression2
Palbociclib	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	submitted	EID10184 Breast cancer cell lines derived from T-47D (vector control, overexpress cyclin E1, overexpress cyclin E2) were treated with CDK4/6 inhibitor PD0332991 and CDK2 inhibitor SNS-032 as single agents and … (full text at CIViC) PMID 22564725 · Caldon et al., 2012 · Open in CIViC	civic
CDK Inhibitor SNS-032 + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	D	Does Not Support Sensitivity Response	3	submitted	EID10185 Breast cancer cell lines derived from T-47D (vector control, overexpress cyclin E1, overexpress cyclin E2) were treated with CDK4/6 inhibitor PD0332991 and CDK2 inhibitor SNS-032 as single agents and … (full text at CIViC) PMID 22564725 · Caldon et al., 2012 · Open in CIViC	civic

FGFR1 Amplification2
Erdafitinib + Fulvestrant + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Does Not Support Sensitivity Response	1	submitted	EID12485 Hormone-receptor positive HER2-negative (HR+) breast cancers can harbor alterations in fibroblast growth factor receptors (FGFRs), particularly FGFR1 amplification, which is associated with poor progn… (full text at CIViC) PMID 40627530 · Gonzalez-Ericsson et al., 2025 · Open in CIViC	civic
Fulvestrant + Palbociclib + RogaratinibCombination	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID12503 To determine if there is a causal relationship between hormonal blockade (a frequent treatment for tumors in the adjuvant setting) and FGFR1 amplification/overexpression, this study used two non-FGFR1… (full text at CIViC) PMID 33579347 · Mouron et al., 2021 · Open in CIViC	civic