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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jun 27, 2008 | Oxaliplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELOXATIN (DIN 02296276) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database —… | DIN02296276 | withdrawnsource: Cancelled Post Marketsince Aug 4, 2016 | health-canada-dpd |
| Jun 27, 2008 | Oxaliplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELOXATIN (DIN 02296268) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database —… | DIN02296268 | withdrawnsource: Cancelled Post Marketsince Aug 3, 2016 | health-canada-dpd |
| Jun 23, 2008 | Panitumumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-23 (see label) | SUPPLBLA125147 | approved | openfda |
| Jun 20, 2008 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-20 (see label) | SUPPLNDA021602 | approved | openfda |
| Jun 10, 2008 | Lapatinib | EMA EU | Malignant Breast Neoplasm | Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with… | centralisedEMEA/H/C/000795 | approved | ema |
| Jun 10, 2008 | Doxorubicin | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-10 (see label) | SUPPLNDA050718 | approved | openfda |
| Jun 3, 2008 | Zoledronic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2008-06-03 (see label) | SUPPLNDA021817 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 2008 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METOJECT (DIN 02304767) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database —… | DIN02304767 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 16, 2008 | Thalidomide | EMA EU | Multiple Myeloma | Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 20, 2008 | Bendamustine | FDA US | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a… | ORIGNDA022249 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 22, 2008 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-02-22 (see label) | SUPPLBLA125085 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 30, 2008 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE TRIHYDRATE INJECTION (DIN 02305143) under ATC L01CE02 IRINOTECAN. Indications are not… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 27, 2007 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02298783) under ATC L01BC05 GEMCITABINE. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 20, 2007 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE HYDROCHLORIDE FOR INJECTION (DIN 02302101) under ATC L01BC05 GEMCITABINE. Indications are not published… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 29, 2007 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOXIFENE - 20 (DIN 02296748) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02296748 |
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: Cancelled Post Marketsince May 19, 2017 |
| health-canada-dpd |
| May 27, 2008 | Panitumumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as VECTIBIX (DIN 02308487) under ATC L01FE02 PANITUMUMAB. Indications are not published in the Drug Product Database —… | DIN02308487 | approvedsource: Marketed | health-canada-dpd |
| May 22, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-05-22 (see label) | SUPPLBLA103792 | approved | openfda |
| May 22, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-05-22 (see label) | SUPPLBLA103792 | approved | openfda |
| centralisedEMEA/H/C/000823 |
| approved |
| ema |
| Apr 16, 2008 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOM-BICALUTAMIDE (DIN 02281139) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02281139 | withdrawnsource: Cancelled Post Marketsince May 9, 2025 | health-canada-dpd |
| Apr 7, 2008 | Epirubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as EPIRUBICIN HYDROCHLORIDE FOR INJECTION (DIN 02301067) under ATC L01DB03 EPIRUBICIN. Indications are not published in… | DIN02301067 | withdrawnsource: Cancelled Post Marketsince Jan 18, 2019 | health-canada-dpd |
| approved |
| openfda |
| Mar 20, 2008 | Bendamustine | FDA US | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | ORIGNDA022249 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 |
| health-canada-dpd |
| Jan 25, 2008 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-25 (see label) | SUPPLBLA103705 | approved | openfda |
| Jan 25, 2008 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02298775) under ATC L01BC05 GEMCITABINE. Indications are not published in the… | DIN02298775 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2018 | health-canada-dpd |
| Jan 18, 2008 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-18 (see label) | SUPPLBLA103792 | approved | openfda |
| Jan 17, 2008 | Nelarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as ATRIANCE (DIN 02299925) under ATC L01BB07 NELARABINE. Indications are not published in the Drug Product Database —… | DIN02299925 | approvedsource: Marketed | health-canada-dpd |
| Jan 14, 2008 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-14 (see label) | SUPPLNDA021083 | approved | openfda |
| Jan 14, 2008 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2008-01-14 (see label) | SUPPLNDA021110 | approved | openfda |
| Jan 11, 2008 | Paclitaxel | EMA EU | cancer not stated in this record | Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for… | centralisedEMEA/H/C/000778 | approved | ema |
| Jan 11, 2008 | Temsirolimus | Health Canada CA | cancer not stated in this record | Marketed in Canada as TORISEL (DIN 02304104) under ATC L01EG01 TEMSIROLIMUS. Indications are not published in the Drug Product Database —… | DIN02304104 | approvedsource: Marketed | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Aug 1, 2014 |
| health-canada-dpd |
| Dec 20, 2007 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLAN-BICALUTAMIDE (DIN 02302403) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02302403 | withdrawnsource: Cancelled Post Marketsince Jan 9, 2017 | health-canada-dpd |
| Dec 17, 2007 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACLITAXEL FOR INJECTION (DIN 02296624) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug… | DIN02296624 | withdrawnsource: Cancelled Post Marketsince Apr 6, 2021 | health-canada-dpd |
| Dec 14, 2007 | Thyrotropin Alfa | FDA US | cancer not stated in this record | Efficacy supplement 2007-12-14 (see label) | SUPPLBLA020898 | approved | openfda |
| Dec 3, 2007 | Panitumumab | EMA EU | Malignant Colorectal Neoplasm | Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in… | centralisedEMEA/H/C/000741 | approved | ema |
| Dec 3, 2007 | Mitoxantrone | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOXANTRONE INJECTION (DIN 02286300) under ATC L01DB07 MITOXANTRONE. Indications are not published in the Drug… | DIN02286300 | approvedsource: Marketed | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 |
| health-canada-dpd |
| Nov 20, 2007 | Gemcitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as GEMCITABINE HYDROCHLORIDE FOR INJECTION (DIN 02302098) under ATC L01BC05 GEMCITABINE. Indications are not published… | DIN02302098 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2019 | health-canada-dpd |
| Nov 19, 2007 | Temsirolimus | EMA EU | cancer not stated in this record | Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have… | centralisedEMEA/H/C/000799 | approved | ema |
| Nov 19, 2007 | Nilotinib | EMA EU | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic… | centralisedEMEA/H/C/000798 | approved | ema |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib Tosylate | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 16, 2007 | Sorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-16 (see label) | SUPPLNDA021923 | approved | openfda |
| Nov 8, 2007 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-08 (see label) | SUPPLNDA021986 | approved | openfda |
| Nov 8, 2007 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2007-11-08 (see label) | SUPPLNDA021986 | approved | openfda |
| Nov 5, 2007 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-BICALUTAMIDE (DIN 02296063) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02296063 | withdrawnsource: Dormantsince May 14, 2023 | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Jul 27, 2011 |
| health-canada-dpd |
| Oct 29, 2007 | Tamoxifen | Health Canada CA | cancer not stated in this record | Marketed in Canada as TAMOXIFENE - 10 (DIN 02296721) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product… | DIN02296721 | withdrawnsource: Cancelled Post Marketsince Jul 27, 2011 | health-canada-dpd |
| Oct 29, 2007 | Nilotinib | FDA US | cancer not stated in this record | Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid… | ORIGNDA022068 | approved | openfda |