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

health-canada-dpd

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	CA Health Canada	—	Marketed in Canada as M-LETROZOLE (DIN 02549972) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 25, 2025	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as JAMP LETROZOLE TABLETS (DIN 02541912) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 20, 2024	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AG-LETROZOLE TABLETS (DIN 02543419) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 20, 2024	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02524244) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 18, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as NRA-LETROZOLE (DIN 02520486) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 25, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AG-LETROZOLE (DIN 02374439) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 3, 2026	Feb 3, 2022	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MINT-LETROZOLE (DIN 02508109) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 20, 2021	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02504472) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 19, 2021	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as CCP-LETROZOLE (DIN 02459884) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 3, 2023	Jul 24, 2017	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as VAN-LETROZOLE (DIN 02428156) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 7, 2019	Jun 8, 2015	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as NAT-LETROZOLE (DIN 02421585) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 3, 2015	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as RIVA-LETROZOLE (DIN 02398656) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 11, 2014	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as TEVA-LETROZOLE (DIN 02343657) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 8, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ZINDA-LETROZOLE (DIN 02378213) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 17, 2018	Jun 18, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as AURO-LETROZOLE (DIN 02404400) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Apr 24, 2015	Jun 12, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02402025) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 14, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as BIO-LETROZOLE (DIN 02392496) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 12, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MAR-LETROZOLE (DIN 02373424) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 8, 2013	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as APO-LETROZOLE (DIN 02358514) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 11, 2012	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as TARO-LETROZOLE (DIN 02372282) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Nov 22, 2022	Oct 4, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as JAMP-LETROZOLE (DIN 02373009) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 3, 2026	Sep 30, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MYL-LETROZOLE (DIN 02372169) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 28, 2016	Sep 8, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02348896) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 25, 2014	Aug 29, 2011	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ACH-LETROZOLE (DIN 02338459) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 3, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02347997) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Dec 10, 2013	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MED-LETROZOLE (DIN 02322315) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince May 25, 2018	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE (DIN 02348969) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 18, 2018	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PMS-LETROZOLE (DIN 02309114) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 28, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as SANDOZ LETROZOLE (DIN 02344815) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 27, 2010	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as FEMARA (DIN 02231384) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 18, 1997	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PHL-LETROZOLE (DIN 02316366) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 13, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as MYLAN-LETROZOLE (DIN 02322544) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Nov 2, 2016	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as CO LETROZOLE (DIN 02352052) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Sep 1, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as IPG-LETROZOLE (DIN 02370794) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE SUN (DIN 02375273) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 11, 2022	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as LETROZOLE TABLETS (DIN 02381958) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Mar 10, 2023	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as ACCEL-LETROZOLE TABLETS USP (DIN 02406330) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 19, 2017	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as DOM-LETROZOLE (DIN 02316374) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 30, 2025	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as PRIVA-LETROZOLE (DIN 02504286) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 29, 2022	—	health-canada-dpd
Letrozole	CA Health Canada	—	Marketed in Canada as STASON-LETROZOLE (DIN 02431335) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jun 27, 2018	—	health-canada-dpd
Letrozole	US FDA	—	Efficacy supplement 2010-04-30 (see label)	approved	Apr 30, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2010-03-02 (see label)	approved	Mar 2, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2010-03-02 (see label)	approved	Mar 2, 2010	openfda
Letrozole	US FDA	—	Efficacy supplement 2005-12-28 (see label)	approved	Dec 28, 2005	openfda
Letrozole	US FDA	—	Efficacy supplement 2004-10-29 (see label)	approved	Oct 29, 2004	openfda
Letrozole	US FDA	—	Efficacy supplement 2003-02-26 (see label)	approved	Feb 26, 2003	openfda
Letrozole	US FDA	—	Efficacy supplement 2003-01-17 (see label)	approved	Jan 17, 2003	openfda
Letrozole	US FDA	—	Efficacy supplement 2001-01-10 (see label)	approved	Jan 10, 2001	openfda
Letrozole	US FDA	Malignant Breast Neoplasm	First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer.	approved	Jul 25, 1997	openfda
Letrozole	US FDA	Malignant Breast Neoplasm	Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.	approved	Jul 25, 1997	openfda