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

ema

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
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