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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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
Feed
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 11, 2021 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-ABIRATERONE (DIN 02501503) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02501503 | approvedsource: Marketed | health-canada-dpd |
| Jan 11, 2021 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-ABIRATERONE (DIN 02492601) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02492601 | approvedsource: Marketed | health-canada-dpd |
| Jan 7, 2021 | Darolutamide | FDA US | cancer not stated in this record | Efficacy supplement 2021-01-07 (see label) | SUPPLNDA212099 | approved | openfda |
| Jan 7, 2021 | Tagraxofusp | EMA EU | Blastic Plasmacytoid Dendritic Cell Neoplasm | Elzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm… | centralisedEMEA/H/C/005031 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 23, 2020 | Gefitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP GEFITINIB (DIN 02500663) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product Database… | DIN02500663 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 25, 2020 | Polatuzumab Vedotin | Health Canada CA | cancer not stated in this record | Marketed in Canada as POLIVY (DIN 02499614) under ATC L01FX14 POLATUZUMAB VEDOTIN. Indications are not published in the Drug Product… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 23, 2020 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-23 (see label) | SUPPLNDA203415 | 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 |
| Dec 23, 2020 | Sonidegib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ODOMZO (DIN 02500337) under ATC L01XJ02 SONIDEGIB. Indications are not published in the Drug Product Database — see… | DIN02500337 | approvedsource: Marketed | health-canada-dpd |
| Dec 21, 2020 | Trastuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with… | centralisedEMEA/H/C/005386 | approved | ema |
| Dec 21, 2020 | Pertuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with… | centralisedEMEA/H/C/005386 | approved | ema |
| Dec 18, 2020 | Relugolix | FDA US | Malignant Prostate Neoplasm | ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH)… | ORIGNDA214621 | approved | openfda |
| Dec 18, 2020 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myeloma Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed… | centralisedEMEA/H/C/005306 | approved | ema |
| Dec 18, 2020 | Selinexor | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA212306 | approved | openfda |
| Dec 18, 2020 | Ponatinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA203469 | approved | openfda |
| Dec 18, 2020 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA208065 | approved | openfda |
| Dec 18, 2020 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA208065 | approved | openfda |
| Dec 18, 2020 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA205552 | approved | openfda |
| Dec 18, 2020 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA210563 | approved | openfda |
| Dec 18, 2020 | Cabazitaxel | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLNDA201023 | approved | openfda |
| Dec 18, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLBLA761034 | approved | openfda |
| Dec 18, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-18 (see label) | SUPPLBLA761034 | approved | openfda |
| Dec 16, 2020 | Margetuximab | FDA US | HER2-Positive Breast Carcinoma | MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer… | ORIGBLA761150 | approved | openfda |
| Dec 14, 2020 | Tirbanibulin | FDA US | cancer not stated in this record | KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor… | ORIGNDA213189 | approved | openfda |
| Dec 14, 2020 | Brexucabtagene Autoleucel | EMA EU | cancer not stated in this record | Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after… | centralisedEMEA/H/C/005102 | approved | ema |
| Dec 10, 2020 | Ripretinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as QINLOCK (DIN 02500833) under ATC L01EX19 RIPRETINIB. Indications are not published in the Drug Product Database — see… | DIN02500833 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2020 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-09 (see label) | SUPPLNDA208065 | approved | openfda |
| Dec 9, 2020 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-09 (see label) | SUPPLNDA208065 | approved | openfda |
| Dec 7, 2020 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-12-07 (see label) | SUPPLNDA208558 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 24, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ACH-IMATINIB (DIN 02490994) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02490994 | approvedsource: Marketed | health-canada-dpd |
| Nov 24, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ACH-IMATINIB (DIN 02490986) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02490986 | approvedsource: Marketed | health-canada-dpd |
| Nov 24, 2020 | Midostaurin | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-24 (see label) | SUPPLNDA207997 | approved | openfda |
| Nov 24, 2020 | Enasidenib | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-24 (see label) | SUPPLNDA209606 | approved | openfda |
| Nov 20, 2020 | Pomalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-20 (see label) | SUPPLNDA204026 | approved | openfda |
| Nov 20, 2020 | Lonafarnib | FDA US | cancer not stated in this record | ZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of… | ORIGNDA213969 | approved | openfda |
| Nov 20, 2020 | Apalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-20 (see label) | SUPPLNDA210951 | approved | openfda |
| Nov 18, 2020 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/005085 | approved | ema |
| Nov 18, 2020 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-18 (see label) | SUPPLBLA761069 | approved | openfda |
| Nov 18, 2020 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-18 (see label) | SUPPLBLA761069 | approved | openfda |
| Nov 16, 2020 | Melphalan | EMA EU | cancer not stated in this record | High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in… | centralisedEMEA/H/C/005173 | approved | ema |
| Nov 13, 2020 | Larotrectinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VITRAKVI (DIN 02490323) under ATC L01EX12 LAROTRECTINIB. Indications are not published in the Drug Product Database —… | DIN02490323 | approvedsource: Marketed | health-canada-dpd |
| Nov 13, 2020 | Larotrectinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VITRAKVI (DIN 02490315) under ATC L01EX12 LAROTRECTINIB. Indications are not published in the Drug Product Database —… | DIN02490315 | approvedsource: Marketed | health-canada-dpd |
| Nov 13, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-11-13 (see label) | SUPPLBLA125514 | approved | openfda |
| Nov 11, 2020 | Decitabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as INQOVI (DIN 02501600) under ATC L01BC58 DECITABINE, COMBINATIONS. Indications are not published in the Drug Product… | DIN02501600 | approvedsource: Marketed | health-canada-dpd |
| Nov 9, 2020 | Erlotinib | FDA US | cancer not stated in this record | Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. | ORIGANDA091059 | approved | openfda |
| Nov 9, 2020 | Erlotinib | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR… | ORIGANDA091059 | approved | openfda |
| Nov 9, 2020 | Erlotinib | FDA US | Malignant Pancreatic Neoplasm | First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. | ORIGANDA091059 | approved | openfda |
| Nov 9, 2020 | Erlotinib | FDA US | Lung Non-Small Cell Carcinoma | The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon… | ORIGANDA091059 | approved | openfda |
| Nov 5, 2020 | Acalabrutinib | EMA EU | cancer not stated in this record | Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated… | centralisedEMEA/H/C/005299 | approved | ema |
| Oct 22, 2020 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-22 (see label) | SUPPLNDA211651 | approved | openfda |
| Oct 22, 2020 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as METHOTREXATE INJECTION BP (DIN 02464365) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02464365 | approvedsource: Marketed | health-canada-dpd |