Biomarker · Gene alteration

CDKN2A deletion / loss

Homozygous deletion or loss of CDKN2A (p16INK4a) detected by FISH, sequencing or p16 immunohistochemistry; used as a diagnostic and prognostic marker in mesothelioma, glioma and other tumors.

CI-BIO-00000035CDKN2A graph →NCIt C41615

Also calledCDKN2A loss · p16 loss · CDKN2A homozygous deletion · 9p21 deletion

Derived

Associated cancers (11)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Cutaneous Melanoma	2	2	—	—	0 / 0 / 0 / 2 / 0
Lung Non-Small Cell Carcinoma	2	2	—	—	0 / 2 / 0 / 0 / 0
Acute Lymphoblastic Leukemia	1	—	1	—	0 / 1 / 0 / 0 / 0
Bladder Urothelial Carcinoma	1	1	—	—	0 / 1 / 0 / 0 / 0

Derived

Drugs with predictive evidence (5)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
PalbociclibSmall Molecule	10	9	1	B	7 / 0	Cutaneous Melanoma, Dermatofibrosarcoma Protuberans, Ewing Sarcoma, Lung Non-Small Cell Carcinoma +4
AlvocidibSmall Molecule	1	1	—

Curated evidence

Predictive evidence items (12)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–12 of 12 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
CDKN2A Loss9
Immune Checkpoint Inhibitor

Regulatory

Approvals mentioning the linked drugs (91)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfda

Clinical trials

Active trials (17)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 10 recruiting · 2 active phase 3 · 50 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–17 of 17 active 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
NCT04931342	A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors(BOUQUET)	active not recruiting

Literature

Linked publications (12)

Publications linked to the scope variant(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–12 of 12 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Pediatric low-grade gliomas can be molecularly stratified for risk.
· Acta Neuropathol · 2018 · PMID 29948154 · validated civic_curation pubmed
Prognostic significance of CDKN2A/B deletions in acute lymphoblastic leukaemia: a meta-analysis.
· Ann Med · 2019 · PMID 30592434 · validated civic_curation pubmed
Palbociclib in Patients With Pancreatic and Biliary Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.
· JCO Precis Oncol · 2019 · PMID 35100714 · validated civic_curation pubmed
Palbociclib in Patients With Non-Small-Cell Lung Cancer With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.
· JCO Precis Oncol · 2020 · PMID 35050752

CDKN2A Loss + CDKN2A Mutation2
Palbociclib	Malignant Biliary Tract NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11654 A phase II clinical study conducted in 10 patients with biliary cancer with CDKN2A loss or mutation, that were treated with palbociclib. No clinical activity demonstrated in patients with CDKN2A mutat… (full text at CIViC) PMID 35100714 · Al Baghdadi et al., 2019 · Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11653 A phase II clinical study conducted with 12 patients with pancreatic cancer with CDKN2A loss or mutation treated with palbociclib. No clinical activity demonstrated in patients with CDKN2A mutated/del… (full text at CIViC) PMID 35100714 · Al Baghdadi et al., 2019 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Letrozole	US FDA	Malignant Breast Neoplasm	Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy.	approved	Jul 25, 1997	openfda
Palbociclib	CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552124) 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
Palbociclib	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
Palbociclib	CA Health Canada	—	Marketed in Canada as PMS-PALBOCICLIB (DIN 02552132) 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
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547651) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547643) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as TARO-PALBOCICLIB (DIN 02547635) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 17, 2024	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493535) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493551) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02493543) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 21, 2020	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453150) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 20, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453177) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 19, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as IBRANCE (DIN 02453169) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 6, 2024	Apr 19, 2016	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570157) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570130) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	CA Health Canada	—	Marketed in Canada as NAT-PALBOCICLIB (DIN 02570149) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Palbociclib	EU EMA	Malignant Breast Neoplasm	Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.	approved	Jun 19, 2026	ema
Palbociclib	EU EMA	Malignant Breast Neoplasm	Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.	approved	Nov 9, 2016	ema
Palbociclib	US FDA	—	Efficacy supplement 2026-06-24 (see label)	approved	Jun 24, 2026	openfda
Palbociclib	US FDA	—	Efficacy supplement 2026-06-24 (see label)	approved	Jun 24, 2026	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-09-16 (see label)	approved	Sep 16, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-09-16 (see label)	approved	Sep 16, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-04-23 (see label)	approved	Apr 23, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2025-04-23 (see label)	approved	Apr 23, 2025	openfda
Palbociclib	US FDA	—	Efficacy supplement 2023-09-06 (see label)	approved	Sep 6, 2023	openfda
Palbociclib	US FDA	—	Efficacy supplement 2023-09-06 (see label)	approved	Sep 6, 2023	openfda
Palbociclib	US FDA	—	Efficacy supplement 2022-12-13 (see label)	approved	Dec 13, 2022	openfda
Palbociclib	US FDA	—	Efficacy supplement 2022-12-13 (see label)	approved	Dec 13, 2022	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2‑positive locally advanced or metastatic breast cancer following induction treatment.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following recurrence on or after completing adjuvant endocrine therapy.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	—	; or o fulvestrant in patients with disease progression following endocrine therapy.	approved	Nov 1, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2019-09-09 (see label)	approved	Sep 9, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2019-04-04 (see label)	approved	Apr 4, 2019	openfda
Palbociclib	US FDA	—	Efficacy supplement 2018-02-06 (see label)	approved	Feb 6, 2018	openfda
Palbociclib	US FDA	—	Efficacy supplement 2017-03-31 (see label)	approved	Mar 31, 2017	openfda
Palbociclib	US FDA	—	Efficacy supplement 2016-02-19 (see label)	approved	Feb 19, 2016	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	—	; or o fulvestrant in patients with disease progression following endocrine therapy.	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy	approved	Feb 3, 2015	openfda
Palbociclib	US FDA	Malignant Breast Neoplasm	in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2 positive locally advanced or metastatic breast cancer following induction treatment.	approved	Feb 3, 2015	openfda