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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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
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 |
|---|---|---|---|---|---|---|---|
| Aug 25, 2021 | Cyclophosphamide | FDA US | cancer not stated in this record | Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas… | ORIGNDA210735 | approved | openfda |
| Aug 20, 2021 | Abiraterone Acetate | EMA EU | Castration-Resistant Prostate Carcinoma | Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive… | centralisedEMEA/H/C/005368 | approved | ema |
| Aug 19, 2021 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-08-19 (see label) | SUPPLBLA125554 | approved | openfda |
| Aug 18, 2021 | Idecabtagene Vicleucel | EMA EU | Multiple Myeloma | Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior… | centralisedEMEA/H/C/004662 | approved | ema |
| Aug 13, 2021 | Belzutifan | FDA US | cancer not stated in this record | von Hippel-Lindau (VHL) disease for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated… | ORIGNDA215383 | approved | openfda |
| Aug 13, 2021 | Belzutifan | FDA US | Clear Cell Renal Cell Carcinoma | as monotherapy, for treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed… | ORIGNDA215383 | approved | openfda |
| Aug 13, 2021 | Belzutifan | FDA US | Clear Cell Renal Cell Carcinoma | Renal Cell Carcinoma with a Clear Cell Component (ccRCC) in combination with pembrolizumab or pembrolizumab and berahyaluronidase… | ORIGNDA215383 | approved | openfda |
| Aug 10, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-08-10 (see label) | SUPPLBLA125514 | approved | openfda |
| Aug 10, 2021 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-08-10 (see label) | SUPPLNDA206947 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 30, 2021 | Romidepsin | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-30 (see label) | SUPPLNDA022393 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 28, 2021 | Sotorasib | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued… | ORIG |
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 26, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-26 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 26, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-26 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 21, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-21 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 21, 2021 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-21 (see label) | SUPPLNDA206947 | approved | openfda |
| Jul 20, 2021 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-LETROZOLE (DIN 02508109) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database… | DIN02508109 | approvedsource: Marketed | health-canada-dpd |
| Jul 15, 2021 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-15 (see label) | SUPPLBLA125554 | approved | openfda |
| Jul 9, 2021 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-09 (see label) | SUPPLBLA761137 | approved | openfda |
| Jul 9, 2021 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-09 (see label) | SUPPLBLA761137 | approved | openfda |
| Jul 6, 2021 | Cytarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VYXEOS (DIN 02515490) under ATC L01XY01 CYTARABINE AND DAUNORUBICIN. Indications are not published in the Drug… | DIN02515490 | approvedsource: Marketed | health-canada-dpd |
| Jul 6, 2021 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as VYXEOS (DIN 02515490) under ATC L01XY01 CYTARABINE AND DAUNORUBICIN. Indications are not published in the Drug… | DIN02515490 | approvedsource: Marketed | health-canada-dpd |
| Jul 5, 2021 | Encorafenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BRAFTOVI (DIN 02513099) under ATC L01EC03 ENCORAFENIB. Indications are not published in the Drug Product Database —… | DIN02513099 | approvedsource: Marketed | health-canada-dpd |
| Jul 5, 2021 | Binimetinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MEKTOVI (DIN 02513080) under ATC L01EE03 BINIMETINIB. Indications are not published in the Drug Product Database —… | DIN02513080 | approvedsource: Marketed | health-canada-dpd |
| Jul 1, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-07-01 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 25, 2021 | Vinorelbine | Health Canada CA | cancer not stated in this record | Marketed in Canada as VINORELBINE INJECTION, USP (DIN 02511347) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug… | DIN02511347 | approvedsource: Marketed | health-canada-dpd |
| Jun 24, 2021 | Abiraterone Acetate | EMA EU | Castration-Resistant Prostate Carcinoma | Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive… | centralisedEMEA/H/C/005649 | approved | ema |
| Jun 17, 2021 | Selumetinib | EMA EU | cancer not stated in this record | Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric… | centralisedEMEA/H/C/005244 | approved | ema |
| Jun 17, 2021 | Azacitidine | EMA EU | Acute Myeloid Leukemia | Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or… | centralisedEMEA/H/C/004761 | approved | ema |
| Jun 16, 2021 | Avapritinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-06-16 (see label) | SUPPLNDA212608 | approved | openfda |
| Jun 16, 2021 | Avapritinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-06-16 (see label) | SUPPLNDA212608 | approved | openfda |
| approved |
| openfda |
| May 28, 2021 | Sotorasib | FDA US | Malignant Colorectal Neoplasm | KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS… | ORIGNDA214665 | approved | openfda |
| May 28, 2021 | Sotorasib | FDA US | Lung Non-Small Cell Carcinoma | KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients… | ORIGNDA214665 | approved | openfda |
| May 28, 2021 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02498103) under ATC L01AA09 BENDAMUSTINE. Indications are not published… | DIN02498103 | withdrawnsource: Cancelled Post Marketsince Sep 25, 2025 | health-canada-dpd |
| May 25, 2021 | Leuprolide | FDA US | Malignant Prostate Neoplasm | CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH)… | ORIGNDA211488 | approved | openfda |
| May 25, 2021 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-05-25 (see label) | SUPPLBLA125377 | approved | openfda |
| May 21, 2021 | Amivantamab | FDA US | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients… | ORIGBLA761210 | approved | openfda |
| May 21, 2021 | Amivantamab | FDA US | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated… | ORIGBLA761210 | approved | openfda |
| May 21, 2021 | Amivantamab | FDA US | Lung Non-Small Cell Carcinoma | Previously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and… | ORIGBLA761210 | approved | openfda |
| May 21, 2021 | Amivantamab | FDA US | Lung Non-Small Cell Carcinoma | First-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with… | ORIGBLA761210 | approved | openfda |
| May 20, 2021 | Fedratinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as INREBIC (DIN 02502445) under ATC L01EJ02 FEDRATINIB. Indications are not published in the Drug Product Database — see… | DIN02502445 | approvedsource: Marketed | health-canada-dpd |
| May 20, 2021 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-05-20 (see label) | SUPPLBLA125554 | approved | openfda |
| May 19, 2021 | Duvelisib | EMA EU | cancer not stated in this record | Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL)… | centralisedEMEA/H/C/005381 | withdrawnsince Feb 16, 2026 | ema |
| May 14, 2021 | Bosutinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-05-14 (see label) | SUPPLNDA203341 | approved | openfda |
| May 12, 2021 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2021-05-12 (see label) | SUPPLNDA210326 | approved | openfda |
| May 7, 2021 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-PEMETREXED (DIN 02480492) under ATC L01BA04 PEMETREXED. Indications are not published in the Drug Product… | DIN02480492 | approvedsource: Marketed | health-canada-dpd |
| May 6, 2021 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02509172) under ATC L01AA09 BENDAMUSTINE. Indications are not published… | DIN02509172 | withdrawnsource: Dormantsince Jul 31, 2023 | health-canada-dpd |
| May 6, 2021 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02509164) under ATC L01AA09 BENDAMUSTINE. Indications are not published… | DIN02509164 | withdrawnsource: Dormantsince Jul 31, 2024 | health-canada-dpd |
| May 5, 2021 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-DASATINIB (DIN 02478358) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02478358 | approvedsource: Marketed | health-canada-dpd |
| May 5, 2021 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-DASATINIB (DIN 02478331) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02478331 | approvedsource: Marketed | health-canada-dpd |