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Regulatory
Every record is one authority's decision for one application or DIN, shown with its jurisdiction, date, indication text as published and status. A molecule approved in one jurisdiction for one indication is not 'approved' in general.
RegulatoryDevelopment pipeline →Methodology
Coverage
Counts of records, not of drugs approved: one application can carry several dated records (original approval, efficacy supplements, one row per DIN in Canada).
Approval records
4,342
Distinct drugs
373
Records naming a cancer
982
Dated in the last 12 months
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |
|---|---|---|---|---|---|---|---|
| FDA | US | 2,343 | 304 | 2,343 | 0 | 115 | Sep 18, 2026 |
| Health Canada | CA | 1,538 | 273 | 979 | 559 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days agoSource updated unknown3 authority · jurisdiction pairs ingested
Feed
Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 13, 2019 | Gefitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-GEFITINIB (DIN 02491796) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database… | DIN02491796 | withdrawnsource: Dormantsince Mar 1, 2026 | health-canada-dpd |
| Nov 5, 2019 | Erlotinib Hydrochloride | FDA US | cancer not stated in this record | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | ORIGANDA211960 | approved | openfda |
| Nov 5, 2019 | Erlotinib Hydrochloride | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR… | ORIGANDA211960 | approved | openfda |
| Nov 5, 2019 | Erlotinib Hydrochloride | FDA US | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine. | ORIGANDA211960 | approved | openfda |
| Nov 5, 2019 | Erlotinib Hydrochloride | FDA US | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon… | ORIGANDA211960 | approved | openfda |
| Nov 1, 2019 | Palbociclib | FDA US | cancer not stated in this record | ; or o fulvestrant in patients with disease progression following endocrine therapy. | ORIGNDA212436 | approved | openfda |
| Nov 1, 2019 | Palbociclib | FDA US | Malignant Breast Neoplasm | in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with… | ORIGNDA212436 | approved | openfda |
| Nov 1, 2019 | Palbociclib | FDA US | Malignant Breast Neoplasm | in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive,… | ORIGNDA212436 | approved | openfda |
| Nov 1, 2019 | Palbociclib | FDA US | Malignant Breast Neoplasm | for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced… | ORIGNDA212436 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 28, 2019 | Elotuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-10-28 (see label) | SUPPLBLA761035 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 19, 2019 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Monotherapy CLIGAVYX is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2019 | Nelarabine | FDA US | cancer not stated in this record | Efficacy supplement 2019-07-31 (see label) | SUPPLNDA021877 | approved | openfda |
| Jul 30, 2019 |
A record is one authority's decision for one application/DIN; the same molecule appears once per jurisdiction and indication. Health Canada DPD does not publish indications — its records state the brand, DIN and ATC class only, and a cancelled or dormant DIN is the status of one product, not of the molecule. FDA cancer mappings come from label text and are flagged probabilistic on the drug page.
| Oct 24, 2019 | Gilteritinib | EMA EU | Acute Myeloid Leukemia | Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with… | centralisedEMEA/H/C/004752 | approved | ema |
| Oct 22, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRAZIMERA (DIN 02483475) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02483475 | approvedsource: Marketed | health-canada-dpd |
| Oct 22, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRAZIMERA (DIN 02483467) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02483467 | approvedsource: Marketed | health-canada-dpd |
| Oct 21, 2019 | Lenvatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LENVIMA (DIN 02484129) under ATC L01EX08 LENVATINIB. Indications are not published in the Drug Product Database — see… | DIN02484129 | approvedsource: Marketed | health-canada-dpd |
| Oct 21, 2019 | Lenvatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LENVIMA (DIN 02484056) under ATC L01EX08 LENVATINIB. Indications are not published in the Drug Product Database — see… | DIN02484056 | approvedsource: Marketed | health-canada-dpd |
| Oct 16, 2019 | Atezolizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECENTRIQ (DIN 02492393) under ATC L01FF05 ATEZOLIZUMAB. Indications are not published in the Drug Product Database —… | DIN02492393 | approvedsource: Marketed | health-canada-dpd |
| Oct 8, 2019 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZEULIDE DEPOT (DIN 02462699) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product… | DIN02462699 | approvedsource: Marketed | health-canada-dpd |
| Oct 8, 2019 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZEULIDE DEPOT (DIN 02429977) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product… | DIN02429977 | approvedsource: Marketed | health-canada-dpd |
| Oct 6, 2019 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-10-06 (see label) | SUPPLNDA204114 | approved | openfda |
| Oct 6, 2019 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2019-10-06 (see label) | SUPPLNDA202806 | approved | openfda |
| Oct 3, 2019 | Dexamethasone | FDA US | Multiple Myeloma | HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a… | ORIGNDA211379 | approved | openfda |
| Oct 2, 2019 | Acalabrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as CALQUENCE (DIN 02491788) under ATC L01EL02 ACALABRUTINIB. Indications are not published in the Drug Product Database… | DIN02491788 | withdrawnsource: Dormantsince Jul 25, 2025 | health-canada-dpd |
| Oct 1, 2019 | Neratinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-10-01 (see label) | SUPPLNDA208051 | approved | openfda |
| Sep 26, 2019 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-26 (see label) | SUPPLBLA761036 | approved | openfda |
| Sep 25, 2019 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZIRABEV (DIN 02489449) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02489449 | approvedsource: Marketed | health-canada-dpd |
| Sep 25, 2019 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZIRABEV (DIN 02489430) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02489430 | approvedsource: Marketed | health-canada-dpd |
| Sep 24, 2019 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-24 (see label) | SUPPLNDA211651 | approved | openfda |
| Sep 19, 2019 | Larotrectinib | EMA EU | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic… | centralisedEMEA/H/C/004919 | approved | ema |
| Sep 17, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Sep 17, 2019 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-17 (see label) | SUPPLNDA206947 | approved | openfda |
| Sep 17, 2019 | Apalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-17 (see label) | SUPPLNDA210951 | approved | openfda |
| Sep 9, 2019 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-09 (see label) | SUPPLNDA207103 | approved | openfda |
| Sep 6, 2019 | Nintedanib | FDA US | cancer not stated in this record | Efficacy supplement 2019-09-06 (see label) | SUPPLNDA205832 | approved | openfda |
| Sep 4, 2019 | Larotrectinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VITRAKVI (DIN 02490331) under ATC L01EX12 LAROTRECTINIB. Indications are not published in the Drug Product Database —… | DIN02490331 | approvedsource: Marketed | health-canada-dpd |
| ORIGNDA210063 |
| approved |
| openfda |
| Aug 16, 2019 | Fedratinib | FDA US | cancer not stated in this record | INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or… | ORIGNDA212327 | approved | openfda |
| Aug 15, 2019 | Entrectinib | FDA US | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene… | ORIGNDA212725 | approved | openfda |
| Aug 15, 2019 | Entrectinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | ORIGNDA212725 | approved | openfda |
| Aug 2, 2019 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation… | centralisedEMEA/H/C/005300 | withdrawn | ema |
| Aug 2, 2019 | Pexidartinib | FDA US | cancer not stated in this record | TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe… | ORIGNDA211810 | approved | openfda |
| Aug 1, 2019 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as MVASI (DIN 02470756) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see… | DIN02470756 | approvedsource: Marketed | health-canada-dpd |
| Aug 1, 2019 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as MVASI (DIN 02470748) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see… | DIN02470748 | approvedsource: Marketed | health-canada-dpd |
| Darolutamide |
| FDA US |
| Nonmetastatic Castration-Resistant Prostate Carcinoma |
| NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate… |
| ORIGNDA212099 |
| approved |
| openfda |
| Jul 30, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-07-30 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 30, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-07-30 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 19, 2019 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-07-19 (see label) | SUPPLBLA761069 | approved | openfda |
| Jul 3, 2019 | Abemaciclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VERZENIO (DIN 02487136) under ATC L01EF03 ABEMACICLIB. Indications are not published in the Drug Product Database —… | DIN02487136 | approvedsource: Marketed | health-canada-dpd |
| Jul 3, 2019 | Abemaciclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VERZENIO (DIN 02487128) under ATC L01EF03 ABEMACICLIB. Indications are not published in the Drug Product Database —… | DIN02487128 | approvedsource: Marketed | health-canada-dpd |