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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jan 24, 2006 | Thyrotropin Alfa | FDA US | cancer not stated in this record | Efficacy supplement 2006-01-24 (see label) | SUPPLBLA020898 | approved | openfda |
| Jan 6, 2006 | Anagrelide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-ANAGRELIDE (DIN 02274949) under ATC L01XX35 ANAGRELIDE. Indications are not published in the Drug Product… | DIN02274949 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 2, 2005 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as AVASTIN (DIN 02270994) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02270994 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 29, 2005 | Tamoxifen | FDA US | cancer not stated in this record | To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) | ORIGNDA021807 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 29, 2005 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2005-09-29 (see label) | SUPPLBLA125085 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 15, 2005 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELIGARD (DIN 02268892) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database —… | DIN02268892 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 15, 2005 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2005-06-15 (see label) | SUPPLNDA020896 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 13, 2005 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2005-05-13 (see label) | SUPPLBLA103964 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 11, 2005 | Anagrelide | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLAN-ANAGRELIDE (DIN 02253054) under ATC L01XX35 ANAGRELIDE. Indications are not published in the Drug Product… | DIN02253054 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 25, 2005 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-25 (see label) | SUPPLNDA021602 | 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.
| Dec 27, 2005 | Lenalidomide | FDA US | cancer not stated in this record | . • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Chronic Lymphocytic Leukemia | . Limitations of Use: • REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia… | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Marginal Zone Lymphoma | . • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Follicular Lymphoma | . • Previously treated follicular lymphoma (FL), in combination with a rituximab product | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Mantle Cell Lymphoma | . • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Myelodysplastic Syndrome | . • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q… | ORIGNDA021880 | approved | openfda |
| Dec 27, 2005 | Lenalidomide | FDA US | Multiple Myeloma | Multiple myeloma (MM), in combination with dexamethasone | ORIGNDA021880 | approved | openfda |
| Dec 15, 2005 | Triptorelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRELSTAR (DIN 02243856) under ATC L02AE04 TRIPTORELIN. Indications are not published in the Drug Product Database —… | DIN02243856 | approvedsource: Marketed | health-canada-dpd |
| Dec 15, 2005 | Triptorelin | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRELSTAR (DIN 02240000) under ATC L02AE04 TRIPTORELIN. Indications are not published in the Drug Product Database —… | DIN02240000 | approvedsource: Marketed | health-canada-dpd |
| Dec 2, 2005 | Interferon Beta-1a | Health Canada CA | cancer not stated in this record | Marketed in Canada as AVONEX (DIN 02269201) under ATC L03AB07 INTERFERON BETA-1A. Indications are not published in the Drug Product… | DIN02269201 | approvedsource: Marketed | health-canada-dpd |
| Dec 1, 2005 | Sorafenib Tosylate | FDA US | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | ORIGNDA021923 | approved | openfda |
| Dec 1, 2005 | Sorafenib Tosylate | FDA US | Renal Cell Carcinoma | Advanced renal cell carcinoma | ORIGNDA021923 | approved | openfda |
| Dec 1, 2005 | Sorafenib Tosylate | FDA US | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | ORIGNDA021923 | approved | openfda |
| Dec 1, 2005 | Sorafenib | FDA US | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | ORIGNDA021923 | approved | openfda |
| Dec 1, 2005 | Sorafenib | FDA US | Renal Cell Carcinoma | Advanced renal cell carcinoma | ORIGNDA021923 | approved | openfda |
| Dec 1, 2005 | Sorafenib | FDA US | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | ORIGNDA021923 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| openfda |
| Oct 29, 2005 | Tamoxifen | FDA US | Malignant Breast Neoplasm | To reduce the incidence of breast cancer in adult women at high risk | ORIGNDA021807 | approved | openfda |
| Oct 29, 2005 | Tamoxifen | FDA US | Malignant Breast Neoplasm | For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer | ORIGNDA021807 | approved | openfda |
| Oct 29, 2005 | Tamoxifen | FDA US | Malignant Breast Neoplasm | For treatment of adult patients with estrogen receptor-positive metastatic breast cancer | ORIGNDA021807 | approved | openfda |
| Oct 28, 2005 | Nelarabine | FDA US | cancer not stated in this record | ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult… | ORIGNDA021877 | approved | openfda |
| Oct 20, 2005 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2005-10-20 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 20, 2005 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2005-10-20 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 5, 2005 | Exemestane | FDA US | cancer not stated in this record | Efficacy supplement 2005-10-05 (see label) | SUPPLNDA020753 | approved | openfda |
| Sep 19, 2005 | Erlotinib | EMA EU | cancer not stated in this record | Non-small cell lung cancer (NSCLC) Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or… | centralisedEMEA/H/C/000618 | approved | ema |
| Sep 16, 2005 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2005-09-16 (see label) | SUPPLNDA020541 | approved | openfda |
| Sep 15, 2005 | Pegfilgrastim | FDA US | cancer not stated in this record | Efficacy supplement 2005-09-15 (see label) | SUPPLBLA125031 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Aug 11, 2005 | Meloxicam | FDA US | cancer not stated in this record | Efficacy supplement 2005-08-11 (see label) | SUPPLNDA021530 | approved | openfda |
| Jul 27, 2005 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | Efficacy supplement 2005-07-27 (see label) | SUPPLBLA125019 | approved | openfda |
| Jul 19, 2005 | Erlotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARCEVA (DIN 02269023) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see… | DIN02269023 | withdrawnsource: Cancelled Post Marketsince Oct 1, 2024 | health-canada-dpd |
| Jul 19, 2005 | Erlotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARCEVA (DIN 02269015) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database — see… | DIN02269015 | withdrawnsource: Cancelled Post Marketsince Oct 1, 2024 | health-canada-dpd |
| Jun 3, 2005 | Metformin | FDA US | cancer not stated in this record | Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults… | ORIGNDA021748 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jun 28, 2016 |
| health-canada-dpd |
| Apr 5, 2005 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as GLEEVEC (DIN 02253275) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see… | DIN02253275 | approvedsource: Marketed | health-canada-dpd |
| Mar 15, 2005 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-15 (see label) | SUPPLNDA021029 | approved | openfda |
| Mar 14, 2005 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-14 (see label) | SUPPLNDA021588 | approved | openfda |
| Mar 14, 2005 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-14 (see label) | SUPPLNDA021588 | approved | openfda |
| Mar 11, 2005 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-11 (see label) | SUPPLNDA021083 | approved | openfda |
| Mar 11, 2005 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-11 (see label) | SUPPLNDA021110 | approved | openfda |
| Mar 2, 2005 | Epirubicin | FDA US | cancer not stated in this record | Efficacy supplement 2005-03-02 (see label) | SUPPLNDA050778 | approved | openfda |