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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Mar 30, 2009 | Everolimus | FDA US | Renal Cell Carcinoma | Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. | ORIGNDA022334 | approved | openfda |
| Mar 30, 2009 | Everolimus | FDA US | Primitive Neuroectodermal Tumor | Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional… | ORIGNDA022334 | approved | openfda |
| Mar 30, 2009 | Everolimus | FDA US | Malignant Breast Neoplasm | Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of… | ORIGNDA022334 | approved | openfda |
| Mar 24, 2009 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPIRUBICIN HYDROCHLORIDE INJECTION (DIN 02312093) under ATC L01DB03 EPIRUBICIN. Indications are not published in the… | DIN02312093 | withdrawnsource: Dormantsince Jun 19, 2015 | health-canada-dpd |
| Mar 20, 2009 | Bleomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as BLEOMYCIN FOR INJECTION (DIN 02265982) under ATC L01DC01 BLEOMYCIN. Indications are not published in the Drug Product… | DIN02265982 | approvedsource: Marketed | health-canada-dpd |
| Mar 13, 2009 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2009-03-13 (see label) | SUPPLNDA021817 | approved | openfda |
| Mar 6, 2009 | Mifamurtide | EMA EU | Osteosarcoma | Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after… | centralisedEMEA/H/C/000802 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 27, 2009 | Glatiramer | FDA US | cancer not stated in this record | Efficacy supplement 2009-02-27 (see label) | SUPPLNDA020622 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 2009 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METOJECT (DIN 02320053) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database —… | DIN02320053 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 28, 2008 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPIRUBICIN HYDROCHLORIDE INJECTION (DIN 02303892) under ATC L01DB03 EPIRUBICIN. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 31, 2008 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN FOR INJECTION (DIN 02312409) under ATC L01CE02 IRINOTECAN. Indications are not published in the Drug… | DIN02312409 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 2008 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TASIGNA (DIN 02315874) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see… | DIN02315874 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 20, 2008 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2008-08-20 (see label) | SUPPLNDA050794 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 9, 2008 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PRO-BICALUTAMIDE (DIN 02311038) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02311038 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2008 | Verteporfin | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-30 (see label) | SUPPLNDA021119 | approved | openfda |
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.
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Treatment of adults with refractory anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Anaplastic Astrocytoma | Anaplastic astrocytoma. | ORIGNDA022277 | approved | openfda |
| Feb 27, 2009 | Temozolomide | FDA US | Glioblastoma | Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. | ORIGNDA022277 | approved | openfda |
| Feb 21, 2009 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02312816) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02312816 | withdrawnsource: Cancelled Post Marketsince Jul 22, 2011 | health-canada-dpd |
| Feb 21, 2009 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEMODAL (DIN 02312794) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database —… | DIN02312794 | approvedsource: Marketed | health-canada-dpd |
| Feb 17, 2009 | Degarelix | EMA EU | Malignant Prostate Neoplasm | FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced… | centralisedEMEA/H/C/000986 | approved | ema |
| Feb 6, 2009 | Filgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic… | centralisedEMEA/H/C/000918 | approved | ema |
| Feb 6, 2009 | Filgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic… | centralisedEMEA/H/C/000917 | approved | ema |
| withdrawnsource: Cancelled Post Marketsince May 19, 2017 |
| health-canada-dpd |
| Jan 26, 2009 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METOJECT (DIN 02320045) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database —… | DIN02320045 | withdrawnsource: Cancelled Post Marketsince Jul 17, 2019 | health-canada-dpd |
| Jan 26, 2009 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METOJECT (DIN 02320037) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database —… | DIN02320037 | withdrawnsource: Cancelled Post Marketsince Apr 23, 2020 | health-canada-dpd |
| Jan 26, 2009 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METOJECT (DIN 02320029) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database —… | DIN02320029 | withdrawnsource: Cancelled Post Marketsince Jun 29, 2022 | health-canada-dpd |
| Jan 9, 2009 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as ALIMTA (DIN 02306433) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product Database — see… | DIN02306433 | withdrawnsource: Cancelled Post Marketsince Jan 29, 2026 | health-canada-dpd |
| Dec 24, 2008 | Degarelix | FDA US | Malignant Prostate Neoplasm | FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for… | ORIGNDA022201 | approved | openfda |
| Dec 19, 2008 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021817 | approved | openfda |
| Dec 19, 2008 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Dec 19, 2008 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2008-12-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Dec 17, 2008 | Azacitidine | EMA EU | cancer not stated in this record | Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT)… | centralisedEMEA/H/C/000978 | approved | ema |
| Dec 15, 2008 | Plerixafor | FDA US | Multiple Myeloma | Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and… | ORIGNDA022311 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Oct 3, 2012 |
| health-canada-dpd |
| Nov 24, 2008 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPIRUBICIN HYDROCHLORIDE INJECTION (DIN 02264927) under ATC L01DB03 EPIRUBICIN. Indications are not published in the… | DIN02264927 | withdrawnsource: Cancelled Post Marketsince Sep 4, 2017 | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Oct 28, 2008 | Cetuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ERBITUX (DIN 02271249) under ATC L01FE01 CETUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02271249 | approvedsource: Marketed | health-canada-dpd |
| Oct 20, 2008 | Metformin | FDA US | cancer not stated in this record | RIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and… | ORIGNDA021591 | approved | openfda |
| Oct 7, 2008 | Histamine | EMA EU | Acute Myeloid Leukemia | Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with… | centralisedEMEA/H/C/000796 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Sep 26, 2008 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021462 | approved | openfda |
| Sep 26, 2008 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 26, 2008 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-26 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 22, 2008 | Fludarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUDARABINE PHOSPHATE FOR INJECTION USP (DIN 02293846) under ATC L01BB05 FLUDARABINE. Indications are not published… | DIN02293846 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2018 | health-canada-dpd |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/000827 | approved | ema |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/000826 | withdrawnsince Sep 23, 2015 | ema |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated… | centralisedEMEA/H/C/000825 | approved | ema |
| Sep 15, 2008 | Filgrastim | EMA EU | cancer not stated in this record | Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients… | centralisedEMEA/H/C/000824 | withdrawnsince Apr 20, 2011 | ema |
| Sep 10, 2008 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02305526) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug… | DIN02305526 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | health-canada-dpd |
| Sep 8, 2008 | Porfimer | FDA US | cancer not stated in this record | Efficacy supplement 2008-09-08 (see label) | SUPPLNDA020451 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Jun 27, 2008 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02305534) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug… | DIN02305534 | withdrawnsource: Cancelled Post Marketsince Apr 30, 2018 | health-canada-dpd |