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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
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 44 | 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, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 19, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-19 (see label) | SUPPLNDA021588 | approved | openfda |
| Oct 17, 2006 | Docetaxel | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-17 (see label) | SUPPLNDA020449 | approved | openfda |
| Oct 11, 2006 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2006-10-11 (see label) | SUPPLBLA125085 | approved | openfda |
| Oct 6, 2006 | Vorinostat | FDA US | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive,… | ORIGNDA021991 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 24, 2006 | Pegaspargase | FDA US | cancer not stated in this record | Efficacy supplement 2006-07-24 (see label) | SUPPLBLA103411 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2006 | Lenalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2006-06-29 (see label) | SUPPLNDA021880 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 11, 2006 | Mitoxantrone | FDA US | cancer not stated in this record | Mitoxantrone injection, USP (concentrate) is indicated for reducing neurologic disability and/or the frequency of clinical relapses in… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 26, 2006 | Sunitinib | FDA US | cancer not stated in this record | treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. •… | ORIG |
| 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 |
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.
| Sep 29, 2006 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2006-09-29 (see label) | SUPPLBLA103705 | approved | openfda |
| Sep 27, 2006 | Panitumumab | FDA US | Malignant Colorectal Neoplasm | Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS… | ORIGBLA125147 | approved | openfda |
| Sep 27, 2006 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2006-09-27 (see label) | SUPPLNDA021588 | approved | openfda |
| Sep 27, 2006 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2006-09-27 (see label) | SUPPLNDA021588 | approved | openfda |
| Jun 28, 2006 | Dasatinib | FDA US | cancer not stated in this record | Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic… | ORIGNDA021986 | approved | openfda |
| Jun 20, 2006 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2006-06-20 (see label) | SUPPLBLA125085 | approved | openfda |
| Jun 14, 2006 | Topotecan | FDA US | cancer not stated in this record | Efficacy supplement 2006-06-14 (see label) | SUPPLNDA020671 | approved | openfda |
| Jun 2, 2006 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2006-06-02 (see label) | SUPPLNDA021083 | approved | openfda |
| Jun 2, 2006 | Sirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2006-06-02 (see label) | SUPPLNDA021110 | approved | openfda |
| Jun 1, 2006 | Prednisolone | FDA US | cancer not stated in this record | Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in… | ORIGNDA021959 | approved | openfda |
| Jun 1, 2006 | Prednisolone | FDA US | Mycosis Fungoides | Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe… | ORIGNDA021959 | approved | openfda |
| ORIGANDA077356 |
| approved |
| openfda |
| Mar 1, 2006 | Cetuximab | FDA US | cancer not stated in this record | Efficacy supplement 2006-03-01 (see label) | SUPPLBLA125084 | approved | openfda |
| Mar 1, 2006 | Cetuximab | FDA US | cancer not stated in this record | Efficacy supplement 2006-03-01 (see label) | SUPPLBLA125084 | approved | openfda |
| Feb 10, 2006 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2006-02-10 (see label) | SUPPLBLA103705 | approved | openfda |
| approved |
| openfda |
| Jan 26, 2006 | Sunitinib | FDA US | Primitive Neuroectodermal Tumor | treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced… | ORIGNDA021938 | approved | openfda |
| Jan 26, 2006 | Sunitinib | FDA US | Renal Cell Carcinoma | treatment of adult patients with advanced renal cell carcinoma (RCC). | ORIGNDA021938 | approved | openfda |
| Jan 24, 2006 | Thyrotropin Alfa | FDA US | cancer not stated in this record | Efficacy supplement 2006-01-24 (see label) | SUPPLBLA020898 | approved | openfda |
| 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 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 |
| 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 |