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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Apr 1, 2011 | Imatinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2011-04-01 (see label) | SUPPLNDA021588 | approved | openfda |
| Apr 1, 2011 | Imatinib | FDA US | cancer not stated in this record | Efficacy supplement 2011-04-01 (see label) | SUPPLNDA021588 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 29, 2011 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SPRYCEL (DIN 02360829) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see… | DIN02360829 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 28, 2011 | Roflumilast | FDA US | cancer not stated in this record | DALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 29, 2010 | Everolimus | FDA US | cancer not stated in this record | Efficacy supplement 2010-10-29 (see label) | SUPPLNDA022334 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 24, 2010 | Dexamethasone | FDA US | cancer not stated in this record | Efficacy supplement 2010-09-24 (see label) | SUPPLNDA022315 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 13, 2010 | Pazopanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VOTRIENT (DIN 02352303) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see… | DIN02352303 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 9, 2010 | Temsirolimus | FDA US | cancer not stated in this record | Efficacy supplement 2010-07-09 (see label) | SUPPLNDA022088 | 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.
| approvedsource: Marketed |
| health-canada-dpd |
| Mar 25, 2011 | Ipilimumab | FDA US | Esophageal Squamous Cell Carcinoma | Esophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | cancer not stated in this record | in combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Pleural Malignant Mesothelioma | Malignant Pleural Mesothelioma • Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Lung Non-Small Cell Carcinoma | Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Lung Non-Small Cell Carcinoma | Non-Small Cell Lung Cancer (NSCLC) • Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Hepatocellular Carcinoma | Hepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | dMMR Colorectal Carcinoma | Colorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Cutaneous Melanoma | Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have… | ORIGBLA125377 | approved | openfda |
| Mar 25, 2011 | Ipilimumab | FDA US | Melanoma | Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in… | ORIGBLA125377 | approved | openfda |
| Mar 24, 2011 | Imiquimod | FDA US | cancer not stated in this record | Efficacy supplement 2011-03-24 (see label) | SUPPLNDA022483 | approved | openfda |
| Mar 17, 2011 | Eribulin | EMA EU | cancer not stated in this record | Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after… | centralisedEMEA/H/C/002084 | approved | ema |
| Mar 17, 2011 | Cabazitaxel | EMA EU | Malignant Prostate Neoplasm | Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic… | centralisedEMEA/H/C/002018 | approved | ema |
| Mar 17, 2011 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2011-03-17 (see label) | SUPPLNDA021462 | approved | openfda |
| Mar 14, 2011 | Tegafur | EMA EU | cancer not stated in this record | Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).… | centralisedEMEA/H/C/001242 | approved | ema |
| Mar 8, 2011 | Docetaxel | FDA US | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | ORIGNDA022234 | approved | openfda |
| Mar 8, 2011 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA022234 | approved | openfda |
| Mar 8, 2011 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA022234 | approved | openfda |
| Mar 8, 2011 | Docetaxel | FDA US | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with… | ORIGNDA022234 | approved | openfda |
| Mar 8, 2011 | Docetaxel | FDA US | Malignant Breast Neoplasm | Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and… | ORIGNDA022234 | approved | openfda |
| Mar 1, 2011 | Docetaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as DOCETAXEL INJECTION USP (DIN 02361957) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product… | DIN02361957 | approvedsource: Marketed | health-canada-dpd |
| ORIGNDA022522 |
| approved |
| openfda |
| Feb 25, 2011 | Cinacalcet | FDA US | cancer not stated in this record | Efficacy supplement 2011-02-25 (see label) | SUPPLNDA021688 | approved | openfda |
| Feb 22, 2011 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACLITAXEL FOR INJECTION USP (DIN 02320010) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug… | DIN02320010 | withdrawnsource: Dormantsince Aug 3, 2017 | health-canada-dpd |
| Feb 5, 2011 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2011-02-05 (see label) | SUPPLNDA020896 | approved | openfda |
| Feb 2, 2011 | Topotecan | FDA US | Lung Small Cell Carcinoma | Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who… | ORIGNDA200582 | approved | openfda |
| Jan 21, 2011 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast… | centralisedEMEA/H/C/002032 | withdrawnsince Jan 21, 2014 | ema |
| Jan 21, 2011 | Ibandronic Acid | EMA EU | cancer not stated in this record | Concentrate for solution for infusion Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or… | centralisedEMEA/H/C/002025 | approved | ema |
| Jan 14, 2011 | Nilotinib | FDA US | cancer not stated in this record | Efficacy supplement 2011-01-14 (see label) | SUPPLNDA022068 | approved | openfda |
| Jan 6, 2011 | Topotecan | EMA EU | Cervical Carcinoma | Topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or… | centralisedEMEA/H/C/002282 | approved | ema |
| Nov 15, 2010 | Eribulin | FDA US | Liposarcoma | Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. | ORIGNDA201532 | approved | openfda |
| Nov 15, 2010 | Eribulin | FDA US | Malignant Breast Neoplasm | Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior… | ORIGNDA201532 | approved | openfda |
| Oct 28, 2010 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2010-10-28 (see label) | SUPPLNDA021986 | approved | openfda |
| Oct 28, 2010 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2010-10-28 (see label) | SUPPLNDA021986 | approved | openfda |
| Oct 21, 2010 | Bicalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP BICALUTAMIDE (DIN 02357216) under ATC L02BB03 BICALUTAMIDE. Indications are not published in the Drug Product… | DIN02357216 | approvedsource: Marketed | health-canada-dpd |
| Oct 20, 2010 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2010-10-20 (see label) | SUPPLBLA103792 | approved | openfda |
| Oct 12, 2010 | Lenalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2010-10-12 (see label) | SUPPLNDA021880 | approved | openfda |
| Sep 17, 2010 | Ibandronic Acid | EMA EU | cancer not stated in this record | Ibandronic acid 50mg Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications… | centralisedEMEA/H/C/001195 | approved | ema |
| Sep 9, 2010 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2010-09-09 (see label) | SUPPLNDA021344 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Aug 5, 2010 | Trabectedin | Health Canada CA | cancer not stated in this record | Marketed in Canada as YONDELIS (DIN 02351528) under ATC L01CX01 TRABECTEDIN. Indications are not published in the Drug Product Database —… | DIN02351528 | approvedsource: Marketed | health-canada-dpd |
| Jul 1, 2010 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2010-07-01 (see label) | SUPPLNDA021938 | approved | openfda |