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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 yesterdaySource 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 21, 2023 | Talquetamab | EMA EU | Multiple Myeloma | Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at… | centralisedEMEA/H/C/005864 | approved | ema |
| Aug 18, 2023 | Aflibercept | FDA US | cancer not stated in this record | EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet)… | ORIGBLA761355 | approved | openfda |
| Aug 18, 2023 | Melphalan | FDA US | Multiple Myeloma | Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral… | ORIGNDA217110 | approved | openfda |
| Aug 14, 2023 | Elranatamab | FDA US | Multiple Myeloma | ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four… | ORIGBLA761345 | approved | openfda |
| Aug 14, 2023 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as AKEEGA (DIN 02538563) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product… | DIN02538563 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2023 | Niraparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AKEEGA (DIN 02538563) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product… | DIN02538563 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2023 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as AKEEGA (DIN 02538555) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product… | DIN02538555 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2023 | Niraparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AKEEGA (DIN 02538555) under ATC L01XK52 NIRAPARIB AND ABIRATERONE. Indications are not published in the Drug Product… | DIN02538555 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2023 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as VEGZELMA (DIN 02534177) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02534177 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-08-14 (see label) | SUPPLBLA125514 | approved | openfda |
| Aug 14, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-08-14 (see label) | SUPPLBLA125514 | approved | openfda |
| Aug 9, 2023 | Talquetamab | FDA US | Multiple Myeloma | TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior… | ORIGBLA761342 | approved | openfda |
| Aug 9, 2023 | Pralsetinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-08-09 (see label) | SUPPLNDA213721 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2023 | Dostarlimab | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-31 (see label) | SUPPLBLA761174 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 27, 2023 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIOTEPA FOR INJECTION, BP (DIN 02536870) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug… | DIN02536870 |
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.
| Jul 27, 2023 | Anastrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as AG-ANASTROZOLE (DIN 02534118) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product… | DIN02534118 | withdrawnsource: Dormantsince Aug 3, 2026 | health-canada-dpd |
| Jul 21, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-SUNITINIB (DIN 02532220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02532220 | approvedsource: Marketed | health-canada-dpd |
| Jul 21, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-SUNITINIB (DIN 02532204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02532204 | approvedsource: Marketed | health-canada-dpd |
| Jul 20, 2023 | Quizartinib | FDA US | Acute Myeloid Leukemia | VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance… | ORIGNDA216993 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021379 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021379 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021731 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021731 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021343 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021343 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021488 | approved | openfda |
| Jul 20, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-07-20 (see label) | SUPPLNDA021488 | approved | openfda |
| Jul 7, 2023 | Glofitamab | EMA EU | Diffuse Large B-Cell Lymphoma | Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory… | centralisedEMEA/H/C/005751 | approved | ema |
| Jul 6, 2023 | Anastrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as ANASTROZOLE (DIN 02529904) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database… | DIN02529904 | approvedsource: Marketed | health-canada-dpd |
| Jul 5, 2023 | Glofitamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as COLUMVI (DIN 02536560) under ATC L01FX28 GLOFITAMAB. Indications are not published in the Drug Product Database — see… | DIN02536560 | approvedsource: Marketed | health-canada-dpd |
| Jul 5, 2023 | Glofitamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as COLUMVI (DIN 02536552) under ATC L01FX28 GLOFITAMAB. Indications are not published in the Drug Product Database — see… | DIN02536552 | approvedsource: Marketed | health-canada-dpd |
| Jul 4, 2023 | Futibatinib | EMA EU | Cholangiocarcinoma | Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a… | centralisedEMEA/H/C/005627 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Jun 27, 2023 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIOTEPA FOR INJECTION, BP (DIN 02536862) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug… | DIN02536862 | approvedsource: Marketed | health-canada-dpd |
| Jun 20, 2023 | Blinatumomab | FDA US | cancer not stated in this record | Efficacy supplement 2023-06-20 (see label) | SUPPLBLA125557 | approved | openfda |
| Jun 20, 2023 | Blinatumomab | FDA US | cancer not stated in this record | Efficacy supplement 2023-06-20 (see label) | SUPPLBLA125557 | approved | openfda |
| Jun 20, 2023 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2023-06-20 (see label) | SUPPLNDA211651 | approved | openfda |
| Jun 15, 2023 | Glofitamab | FDA US | cancer not stated in this record | COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified… | ORIGBLA761309 | approved | openfda |
| Jun 14, 2023 | Brentuximab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2023-06-14 (see label) | SUPPLBLA125388 | approved | openfda |
| Jun 7, 2023 | Cyclophosphamide | FDA US | cancer not stated in this record | Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of… | ORIGNDA210852 | approved | openfda |
| Margetuximab |
| FDA US |
| cancer not stated in this record |
| Efficacy supplement 2023-05-25 (see label) |
| SUPPLBLA761150 |
| approved |
| openfda |
| May 24, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532883) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product… | DIN02532883 | approvedsource: Marketed | health-canada-dpd |
| May 24, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532867) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product… | DIN02532867 | approvedsource: Marketed | health-canada-dpd |
| May 24, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ SUNITINIB (DIN 02532840) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product… | DIN02532840 | approvedsource: Marketed | health-canada-dpd |
| May 22, 2023 | Pemetrexed | FDA US | Pleural Malignant Mesothelioma | initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are… | ORIGNDA215179 | approved | openfda |
| May 22, 2023 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: PEMRYDI RTU is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA215179 | approved | openfda |
| May 22, 2023 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | ORIGNDA215179 | approved | openfda |
| May 22, 2023 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not… | ORIGNDA215179 | approved | openfda |
| May 22, 2023 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | ORIGNDA215179 | approved | openfda |
| May 22, 2023 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small… | ORIGNDA215179 | approved | openfda |