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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1) | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy… | ORIGNDA021344 | approved | openfda |
| Apr 25, 2002 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not… | ORIGNDA021344 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 7, 2002 | Interferon Beta-1a | FDA US | cancer not stated in this record | REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 19, 2002 | Ibritumomab Tiuxetan | FDA US | cancer not stated in this record | . previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy | ORIGBLA125019 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2002 | Pegfilgrastim | FDA US | cancer not stated in this record | Neulasta is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 21, 2001 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYOCET (DIN 02245015) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug Product Database — see… | DIN02245015 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 14, 2001 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as RATIO-METHOTREXATE SODIUM (DIN 02244798) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 31, 2001 | Paclitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as PACLITAXEL FOR INJECTION (DIN 02244372) under ATC L01CD01 PACLITAXEL. Indications are not published in the Drug… | DIN02244372 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 26, 2001 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as GLEEVEC (DIN 02244725) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see… | DIN02244725 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 22, 2001 | Verteporfin | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-22 (see label) | SUPPLNDA021119 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 11, 2001 | Cytarabine | EMA EU | Meningeal Lymphoma | Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 29, 2001 | Triptorelin | FDA US | Malignant Prostate Neoplasm | TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2001 | Irbesartan | FDA US | cancer not stated in this record | Efficacy supplement 2001-05-26 (see label) | SUPPLNDA020757 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 30, 2001 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2001-04-30 (see label) | SUPPLNDA020896 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 29, 2001 | Bexarotene | EMA EU | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin capsules are indicated for the treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 22, 2001 | Hydroxyurea | Health Canada CA | cancer not stated in this record | Marketed in Canada as MYLAN-HYDROXYUREA (DIN 02242920) under ATC L01XX05 HYDROXYCARBAMIDE. Indications are not published in the Drug… | DIN02242920 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 25, 2001 | Ifosfamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as IFEX (DIN 02241356) under ATC L01AA06 IFOSFAMIDE. Indications are not published in the Drug Product Database — see… | DIN02241356 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 29, 2000 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as DEPOCYT (DIN 02241150) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see… | DIN02241150 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 26, 2000 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as PROCYTOX (DIN 02241797) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published in the Drug Product… | DIN02241797 |
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.
| ORIGBLA103780 |
| approved |
| openfda |
| Mar 5, 2002 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Trisenox is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute… | centralisedEMEA/H/C/000388 | approved | ema |
| openfda |
| Feb 19, 2002 | Ibritumomab Tiuxetan | FDA US | B-Cell Non-Hodgkin Lymphoma | relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) | ORIGBLA125019 | approved | openfda |
| ORIGBLA125031 |
| approved |
| openfda |
| Jan 23, 2002 | Leuprolide | FDA US | Malignant Prostate Neoplasm | VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated… | ORIGNDA021343 | approved | openfda |
| withdrawnsource: Dormantsince Sep 7, 2018 |
| health-canada-dpd |
| Dec 11, 2001 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2001-12-11 (see label) | SUPPLBLA103792 | approved | openfda |
| Dec 3, 2001 | Mitoxantrone | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOXANTRONE INJECTION USP (DIN 02244614) under ATC L01DB07 MITOXANTRONE. Indications are not published in the Drug… | DIN02244614 | withdrawnsource: Cancelled Post Marketsince Mar 26, 2019 | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince May 7, 2018 |
| health-canada-dpd |
| Nov 7, 2001 | Imatinib | EMA EU | cancer not stated in this record | Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia-chromosome (bcr-abl)-positive… | centralisedEMEA/H/C/000406 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Oct 24, 2001 | Temoporfin | EMA EU | Head and Neck Squamous Cell Carcinoma | Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies… | centralisedEMEA/H/C/000318 | approved | ema |
| Oct 18, 2001 | Celecoxib | FDA US | cancer not stated in this record | Efficacy supplement 2001-10-18 (see label) | SUPPLNDA020998 | approved | openfda |
| Oct 12, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-10-12 (see label) | SUPPLNDA020990 | approved | openfda |
| Oct 12, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-10-12 (see label) | SUPPLNDA019839 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Sep 24, 2008 |
| health-canada-dpd |
| Sep 21, 2001 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-21 (see label) | SUPPLNDA020708 | approved | openfda |
| Sep 21, 2001 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-21 (see label) | SUPPLNDA020011 | approved | openfda |
| Sep 18, 2001 | Flutamide | FDA US | Prostate Carcinoma | Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D… | ORIGANDA075298 | approved | openfda |
| Sep 7, 2001 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2001-09-07 (see label) | SUPPLNDA020896 | approved | openfda |
| Aug 6, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-06 (see label) | SUPPLNDA020990 | approved | openfda |
| Aug 6, 2001 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 2001-08-06 (see label) | SUPPLNDA019839 | approved | openfda |
| centralisedEMEA/H/C/000317 |
| withdrawn |
| ema |
| Jul 6, 2001 | Alemtuzumab | EMA EU | Chronic Lymphocytic Leukemia | MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination… | centralisedEMEA/H/C/000353 | withdrawnsince Aug 8, 2012 | ema |
| approved |
| openfda |
| May 7, 2001 | Alemtuzumab | FDA US | Chronic Lymphocytic Leukemia | CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed… | ORIGBLA103948 | approved | openfda |
| Apr 23, 2001 | Valrubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as VALTAXIN (DIN 02242466) under ATC L01DB09 VALRUBICIN. Indications are not published in the Drug Product Database —… | DIN02242466 | withdrawnsource: Cancelled Post Marketsince Aug 1, 2017 | health-canada-dpd |
| centralisedEMEA/H/C/000326 |
| approved |
| ema |
| Mar 27, 2001 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as UNITRON PEG (DIN 02242969) under ATC L03AB10 PEGINTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02242969 | withdrawnsource: Cancelled Post Marketsince Feb 1, 2012 | health-canada-dpd |
| Mar 27, 2001 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as UNITRON PEG (DIN 02242968) under ATC L03AB10 PEGINTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02242968 | withdrawnsource: Cancelled Post Marketsince Feb 1, 2012 | health-canada-dpd |
| Mar 27, 2001 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as UNITRON PEG (DIN 02242967) under ATC L03AB10 PEGINTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02242967 | withdrawnsource: Cancelled Post Marketsince Feb 1, 2012 | health-canada-dpd |
| Mar 27, 2001 | Peginterferon Alfa-2b | Health Canada CA | cancer not stated in this record | Marketed in Canada as UNITRON PEG (DIN 02242966) under ATC L03AB10 PEGINTERFERON ALFA-2B. Indications are not published in the Drug Product… | DIN02242966 | withdrawnsource: Cancelled Post Marketsince Feb 1, 2012 | health-canada-dpd |
| Mar 20, 2001 | Zoledronic Acid | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced… | centralisedEMEA/H/C/000336 | approved | ema |
| Mar 20, 2001 | Ifosfamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as IFEX (DIN 02241357) under ATC L01AA06 IFOSFAMIDE. Indications are not published in the Drug Product Database — see… | DIN02241357 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Feb 2, 2001 | Capecitabine | EMA EU | cancer not stated in this record | Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is… | centralisedEMEA/H/C/000316 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Jan 10, 2001 | Letrozole | FDA US | cancer not stated in this record | Efficacy supplement 2001-01-10 (see label) | SUPPLNDA020726 | approved | openfda |
| withdrawnsource: Cancelled Post Marketsince Jun 29, 2017 |
| health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |