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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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
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Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 19, 2009 | Pazopanib | FDA US | Soft Tissue Sarcoma | advanced soft tissue sarcoma (STS) who have received prior chemotherapy. | ORIGNDA022465 | approved | openfda |
| Oct 19, 2009 | Pazopanib | FDA US | Renal Cell Carcinoma | advanced renal cell carcinoma (RCC). | ORIGNDA022465 | approved | openfda |
| Oct 16, 2009 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2009-10-16 (see label) | SUPPLBLA103705 | approved | openfda |
| Oct 2, 2009 | Topotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as TOPOTECAN FOR INJECTION (DIN 02333880) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product… | DIN02333880 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 | health-canada-dpd |
| Oct 1, 2009 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02318741) under ATC L01BC05 GEMCITABINE. Indications are not published in the… | DIN02318741 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2018 | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 29, 2009 | Sodium Iodide 131 I | Health Canada CA | cancer not stated in this record | Marketed in Canada as HICON (DIN 02482339) under ATC V10XA01 SODIUM IODIDE 131 I. Indications are not published in the Drug Product… | DIN02482339 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colorectal Neoplasm | treatment of advanced colorectal cancer. ( 1 ) | ORIGANDA078813 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2009 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2009-07-31 (see label) | SUPPLBLA125085 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2009 | Sodium Iodide 131 I | Health Canada CA | cancer not stated in this record | Marketed in Canada as DRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP THERAPEUTIC (DIN 02329778) under ATC V10XA01 SODIUM IODIDE 131 I.… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2009 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-29 (see label) | SUPPLNDA021817 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 30, 2009 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2009-04-30 (see label) | SUPPLNDA020541 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 31, 2009 | Vinorelbine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINORELBINE INJECTION (DIN 02265990) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product… | DIN02265990 |
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.
| withdrawnsource: Dormantsince Jul 19, 2019 |
| health-canada-dpd |
| Sep 29, 2009 | Sodium Iodide 131 I | Health Canada CA | cancer not stated in this record | Marketed in Canada as HICON (DIN 02482320) under ATC V10XA01 SODIUM IODIDE 131 I. Indications are not published in the Drug Product… | DIN02482320 | withdrawnsource: Dormantsince Jul 19, 2019 | health-canada-dpd |
| Sep 29, 2009 | Sodium Iodide 131 I | Health Canada CA | cancer not stated in this record | Marketed in Canada as HICON (DIN 02327864) under ATC V10XA01 SODIUM IODIDE 131 I. Indications are not published in the Drug Product… | DIN02327864 | withdrawnsource: Dormantsince Jul 19, 2019 | health-canada-dpd |
| Sep 24, 2009 | Pralatrexate | FDA US | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is… | ORIGNDA022468 | approved | openfda |
| Sep 23, 2009 | Vorinostat | FDA US | cancer not stated in this record | Efficacy supplement 2009-09-23 (see label) | SUPPLNDA021991 | approved | openfda |
| Sep 21, 2009 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or… | centralisedEMEA/H/C/001071 | withdrawn | ema |
| Sep 21, 2009 | Vinflunine | EMA EU | Urothelial Carcinoma | Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the… | centralisedEMEA/H/C/000983 | approved | ema |
| Sep 14, 2009 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPIRUBICIN HYDROCHLORIDE INJECTION (DIN 02324091) under ATC L01DB03 EPIRUBICIN. Indications are not published in the… | DIN02324091 | approvedsource: Marketed | health-canada-dpd |
| Sep 3, 2009 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | Efficacy supplement 2009-09-03 (see label) | SUPPLBLA125019 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colon Neoplasm | adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) | ORIGANDA078813 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colorectal Neoplasm | treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and… | ORIGANDA078813 | approved | openfda |
| Aug 7, 2009 | Oxaliplatin | FDA US | Malignant Colon Neoplasm | adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. | ORIGANDA078813 | approved | openfda |
| Aug 2, 2009 | Everolimus | EMA EU | Renal Cell Carcinoma | Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative… | centralisedEMEA/H/C/001038 | approved | ema |
| Jul 30, 2009 | Plerixafor | EMA EU | cancer not stated in this record | Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the… | centralisedEMEA/H/C/001030 | approved | ema |
| Jul 24, 2009 | Topotecan | EMA EU | cancer not stated in this record | Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the… | centralisedEMEA/H/C/001031 | withdrawnsince Jan 15, 2019 | ema |
| Jul 22, 2009 | Vinorelbine | FDA US | Lung Non-Small Cell Carcinoma | Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic… | ORIGANDA078011 | approved | openfda |
| Jul 16, 2009 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02324210) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug… | DIN02324210 | withdrawnsource: Cancelled Post Marketsince Oct 28, 2025 | health-canada-dpd |
| Jul 2, 2009 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2009-07-02 (see label) | SUPPLNDA021462 | approved | openfda |
| Jul 1, 2009 | Asparaginase | Health Canada CA | cancer not stated in this record | Marketed in Canada as ERWINASE (DIN 02237815) under ATC L01XX02 ASPARAGINASE. Indications are not published in the Drug Product Database —… | DIN02237815 | withdrawnsource: Cancelled Post Marketsince Apr 9, 2021 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Jun 30, 2009 | Sodium Iodide 131 I | Health Canada CA | cancer not stated in this record | Marketed in Canada as DRAXIMAGE SODIUM IODIDE I131 CAPSULES, USP THERAPEUTIC (DIN 02329743) under ATC V10XA01 SODIUM IODIDE 131 I.… | DIN02329743 | approvedsource: Marketed | health-canada-dpd |
| Jun 30, 2009 | Cladribine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CLADRIBINE INJECTION (DIN 02319918) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product… | DIN02319918 | approvedsource: Marketed | health-canada-dpd |
| Jun 29, 2009 | Vorinostat | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZOLINZA (DIN 02327619) under ATC L01XH01 VORINOSTAT. Indications are not published in the Drug Product Database — see… | DIN02327619 | approvedsource: Marketed | health-canada-dpd |
| Jun 24, 2009 | Gefitinib | EMA EU | Lung Non-Small Cell Carcinoma | Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating… | centralisedEMEA/H/C/001016 | approved | ema |
| Jun 22, 2009 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as BICALUTAMIDE (DIN 02325233) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02325233 | withdrawnsource: Cancelled Post Marketsince Jun 20, 2014 | health-canada-dpd |
| Jun 17, 2009 | Dexamethasone | FDA US | cancer not stated in this record | The treatment of non-infectious uveitis affecting the posterior segment of the eye • The treatment of diabetic macular edema | ORIGNDA022315 | approved | openfda |
| Jun 17, 2009 | Dexamethasone | FDA US | Conventional Osteosarcoma | The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) | ORIGNDA022315 | approved | openfda |
| Jun 16, 2009 | Methyl Aminolevulinate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METVIX (DIN 02323273) under ATC L01XD03 METHYL AMINOLEVULINATE. Indications are not published in the Drug Product… | DIN02323273 | approvedsource: Marketed | health-canada-dpd |
| Jun 11, 2009 | Ibuprofen | FDA US | cancer not stated in this record | CALDOLOR is indicated in adults and pediatric patients aged 3 months and older for the: management of mild to moderate pain, including… | ORIGNDA022348 | approved | openfda |
| Jun 9, 2009 | Melphalan | FDA US | Multiple Myeloma | Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is… | ORIGANDA090270 | approved | openfda |
| Jun 5, 2009 | Lapatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TYKERB (DIN 02326442) under ATC L01EH01 LAPATINIB. Indications are not published in the Drug Product Database — see… | DIN02326442 | approvedsource: Marketed | health-canada-dpd |
| May 27, 2009 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-27 (see label) | SUPPLNDA021588 | approved | openfda |
| May 27, 2009 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-27 (see label) | SUPPLNDA021588 | approved | openfda |
| May 21, 2009 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-21 (see label) | SUPPLNDA021986 | approved | openfda |
| May 14, 2009 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBIF (DIN 02318261) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product Database… | DIN02318261 | approvedsource: Marketed | health-canada-dpd |
| May 14, 2009 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as REBIF (DIN 02318253) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product Database… | DIN02318253 | approvedsource: Marketed | health-canada-dpd |
| May 5, 2009 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2009-05-05 (see label) | SUPPLBLA125085 | approved | openfda |
| May 4, 2009 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SPRYCEL (DIN 02320193) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see… | DIN02320193 | approvedsource: Marketed | health-canada-dpd |
| Apr 20, 2009 | Catumaxomab | EMA EU | cancer not stated in this record | Removab is indicated for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard… | centralisedEMEA/H/C/000972 | withdrawnsince Jun 2, 2017 | ema |
| withdrawnsource: Cancelled Post Marketsince Jul 20, 2021 |
| health-canada-dpd |
| Mar 30, 2009 | Everolimus | FDA US | cancer not stated in this record | Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. • AFINITOR and AFINITOR DISPERZ are… | ORIGNDA022334 | approved | openfda |