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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Aug 19, 2011 | Brentuximab Vedotin | FDA US | Classic Hodgkin Lymphoma | Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine,… | ORIGBLA125388 | approved | openfda |
| Aug 17, 2011 | Vemurafenib | FDA US | cancer not stated in this record | ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. | ORIGNDA202429 | approved | openfda |
| Aug 17, 2011 | Vemurafenib | FDA US | Melanoma | Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) | ORIGNDA202429 | approved | openfda |
| Aug 17, 2011 | Vemurafenib | FDA US | Melanoma | ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation… | ORIGNDA202429 | approved | openfda |
| Aug 16, 2011 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as VICTRELIS TRIPLE (DIN 02371472) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published… | DIN02371472 | withdrawnsource: Cancelled Post Marketsince Sep 2, 2016 | health-canada-dpd |
| Aug 16, 2011 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as VICTRELIS TRIPLE (DIN 02371464) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published… | DIN02371464 | withdrawnsource: Cancelled Post Marketsince Sep 2, 2016 | health-canada-dpd |
| Aug 16, 2011 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as VICTRELIS TRIPLE (DIN 02371456) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published… | DIN02371456 | withdrawnsource: Cancelled Post Marketsince Jan 10, 2017 | health-canada-dpd |
| Aug 16, 2011 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as VICTRELIS TRIPLE (DIN 02371448) under ATC L03AB60 PEGINTERFERON ALFA-2B, COMBINATIONS. Indications are not published… | DIN02371448 | withdrawnsource: Cancelled Post Marketsince Jan 10, 2017 | health-canada-dpd |
| Aug 15, 2011 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2011-08-15 (see label) | SUPPLNDA020263 | approved | openfda |
| Aug 9, 2011 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2011-08-09 (see label) | SUPPLBLA103964 | approved | openfda |
| Aug 4, 2011 | Gemcitabine | FDA US | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | ORIGNDA200795 | approved | openfda |
| Aug 4, 2011 | Gemcitabine | FDA US | Lung Non-Small Cell Carcinoma | in combination with cisplatin for the treatment of non-small cell lung cancer. | ORIGNDA200795 | approved | openfda |
| Aug 4, 2011 | Gemcitabine | FDA US | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing… | ORIGNDA200795 | approved | openfda |
| Aug 4, 2011 | Gemcitabine | FDA US | Malignant Ovarian Neoplasm | in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of… | ORIGNDA200795 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 28, 2011 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZYTIGA (DIN 02371065) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product Database — see… | DIN02371065 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 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 | ORIGNDA201525 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 27, 2011 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE TRIHYDRATE FOR INJECTION (DIN 02345080) under ATC L01CE02 IRINOTECAN. Indications are not… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 28, 2011 | Abiraterone Acetate | FDA US | cancer not stated in this record | ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer… |
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 |
| Jul 26, 2011 | Ibandronic Acid | EMA EU | cancer not stated in this record | Ibandronic acid Sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring… | centralisedEMEA/H/C/002367 | withdrawnsince Jan 9, 2024 | ema |
| Jul 15, 2011 | Imiquimod | FDA US | cancer not stated in this record | Efficacy supplement 2011-07-15 (see label) | SUPPLNDA022483 | approved | openfda |
| Jul 15, 2011 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TASIGNA (DIN 02368250) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see… | DIN02368250 | approvedsource: Marketed | health-canada-dpd |
| Jul 13, 2011 | Ipilimumab | EMA EU | cancer not stated in this record | Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic)… | centralisedEMEA/H/C/002213 | approved | ema |
| Jul 13, 2011 | Temozolomide | EMA EU | Glioblastoma | Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with… | centralisedEMEA/H/C/002198 | approved | ema |
| Jul 13, 2011 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/002173 | approved | ema |
| approved |
| openfda |
| Jun 29, 2011 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA201525 | approved | openfda |
| Jun 29, 2011 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA201525 | approved | openfda |
| Jun 29, 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… | ORIGNDA201525 | approved | openfda |
| Jun 29, 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… | ORIGNDA201525 | approved | openfda |
| Jun 27, 2011 | Topotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as TOPOTECAN HYDROCHLORIDE FOR INJECTION (DIN 02344009) under ATC L01CE01 TOPOTECAN. Indications are not published in… | DIN02344009 | approved | health-canada-dpd |
| Jun 17, 2011 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2011-06-17 (see label) | SUPPLNDA020517 | approved | openfda |
| Jun 16, 2011 | Romidepsin | FDA US | cancer not stated in this record | Efficacy supplement 2011-06-16 (see label) | SUPPLNDA022393 | approved | openfda |
| Jun 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 | ORIGNDA201195 | approved | openfda |
| Jun 8, 2011 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA201195 | approved | openfda |
| Jun 8, 2011 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA201195 | approved | openfda |
| Jun 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… | ORIGNDA201195 | approved | openfda |
| Jun 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… | ORIGNDA201195 | approved | openfda |
| withdrawnsource: Dormantsince Aug 3, 2017 |
| health-canada-dpd |
| May 27, 2011 | Peginterferon Alfa-2a | FDA US | cancer not stated in this record | Efficacy supplement 2011-05-27 (see label) | SUPPLBLA103964 | approved | openfda |
| May 20, 2011 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2011-05-20 (see label) | SUPPLNDA021938 | approved | openfda |
| May 17, 2011 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2011-05-17 (see label) | SUPPLNDA021344 | approved | openfda |
| May 5, 2011 | Everolimus | FDA US | cancer not stated in this record | Efficacy supplement 2011-05-05 (see label) | SUPPLNDA022334 | approved | openfda |
| May 3, 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 | ORIGNDA022534 | approved | openfda |
| May 3, 2011 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA022534 | approved | openfda |
| May 3, 2011 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA022534 | approved | openfda |
| May 3, 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… | ORIGNDA022534 | approved | openfda |
| May 3, 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… | ORIGNDA022534 | approved | openfda |
| ORIGNDA202379 |
| approved |
| openfda |
| Apr 28, 2011 | Abiraterone | FDA US | cancer not stated in this record | ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer… | ORIGNDA202379 | approved | openfda |
| Apr 19, 2011 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2011-04-19 (see label) | SUPPLBLA103705 | approved | openfda |
| Apr 18, 2011 | Anastrozole | FDA US | cancer not stated in this record | Efficacy supplement 2011-04-18 (see label) | SUPPLNDA020541 | approved | openfda |
| Apr 11, 2011 | Fludarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUDARABINE PHOSPHATE INJECTION (DIN 02351722) under ATC L01BB05 FLUDARABINE. Indications are not published in the… | DIN02351722 | withdrawnsource: Dormantsince Aug 3, 2017 | health-canada-dpd |
| Apr 6, 2011 | Vandetanib | FDA US | Thyroid Gland Medullary Carcinoma | CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally… | ORIGNDA022405 | approved | openfda |