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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Oct 16, 2020 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-16 (see label) | SUPPLNDA208573 | approved | openfda |
| Oct 16, 2020 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-16 (see label) | SUPPLNDA208573 | approved | openfda |
| Oct 14, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-14 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 8, 2020 | Tucatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TUKYSA (DIN 02499827) under ATC L01EH03 TUCATINIB. Indications are not published in the Drug Product Database — see… | DIN02499827 | approvedsource: Marketed | health-canada-dpd |
| Oct 8, 2020 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-08 (see label) | SUPPLNDA209115 | approved | openfda |
| Oct 5, 2020 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02494930) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02494930 | withdrawnsource: Cancelled Post Marketsince Jul 29, 2026 | health-canada-dpd |
| Oct 2, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-02 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 2, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-02 (see label) | SUPPLBLA125554 | approved | openfda |
| Oct 2, 2020 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-10-02 (see label) | SUPPLBLA125377 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-09-30 (see label) | SUPPLBLA761034 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2020 | Tafasitamab | FDA US | Marginal Zone Lymphoma | Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal… | ORIGBLA761163 |
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.
| Sep 25, 2020 | Tofacitinib | FDA US | cancer not stated in this record | Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. •… | ORIGNDA213082 | approved | openfda |
| Sep 25, 2020 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-09-25 (see label) | SUPPLNDA203214 | approved | openfda |
| Sep 24, 2020 | Avapritinib | EMA EU | cancer not stated in this record | Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the treatment of adult patients… | centralisedEMEA/H/C/005208 | approved | ema |
| Sep 24, 2020 | Bevacizumab | EMA EU | cancer not stated in this record | Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma… | centralisedEMEA/H/C/005181 | withdrawn | ema |
| Sep 21, 2020 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IBRANCE (DIN 02493551) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database —… | DIN02493551 | approvedsource: Marketed | health-canada-dpd |
| Sep 21, 2020 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IBRANCE (DIN 02493543) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database —… | DIN02493543 | approvedsource: Marketed | health-canada-dpd |
| Sep 21, 2020 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as IBRANCE (DIN 02493535) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product Database —… | DIN02493535 | approvedsource: Marketed | health-canada-dpd |
| Sep 18, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-09-18 (see label) | SUPPLBLA125554 | approved | openfda |
| Sep 18, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-09-18 (see label) | SUPPLBLA125554 | approved | openfda |
| Sep 18, 2020 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-09-18 (see label) | SUPPLBLA125377 | approved | openfda |
| Sep 17, 2020 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Arsenic trioxide medac is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed… | centralisedEMEA/H/C/005218 | approved | ema |
| Sep 4, 2020 | Pralsetinib | FDA US | Malignant Thyroid Gland Neoplasm | Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic… | ORIGNDA213721 | approved | openfda |
| Sep 4, 2020 | Pralsetinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA… | ORIGNDA213721 | approved | openfda |
| Sep 1, 2020 | Azacitidine | FDA US | Acute Myeloid Leukemia | ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or… | ORIGNDA214120 | approved | openfda |
| Aug 28, 2020 | Cabazitaxel | EMA EU | Malignant Prostate Neoplasm | Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. | centralisedEMEA/H/C/005178 | approved | ema |
| Aug 27, 2020 | Tucatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TUKYSA (DIN 02499835) under ATC L01EH03 TUCATINIB. Indications are not published in the Drug Product Database — see… | DIN02499835 | approvedsource: Marketed | health-canada-dpd |
| Aug 25, 2020 | Belantamab Mafodotin | EMA EU | Multiple Myeloma | Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior… | centralisedEMEA/H/C/004935 | withdrawnsince Feb 23, 2024 | ema |
| Aug 21, 2020 | Pemetrexed | FDA US | cancer not stated in this record | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small… | ORIGNDA208419 | approved | openfda |
| Aug 21, 2020 | 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… | ORIGNDA208419 | approved | openfda |
| Aug 21, 2020 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA208419 | approved | openfda |
| Aug 21, 2020 | 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. | ORIGNDA208419 | approved | openfda |
| Aug 21, 2020 | 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… | ORIGNDA208419 | approved | openfda |
| Aug 21, 2020 | 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. | ORIGNDA208419 | approved | openfda |
| Aug 20, 2020 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-08-20 (see label) | SUPPLBLA761036 | approved | openfda |
| Aug 20, 2020 | Ofatumumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-08-20 (see label) | SUPPLBLA125326 | approved | openfda |
| Aug 20, 2020 | Carfilzomib | FDA US | cancer not stated in this record | Efficacy supplement 2020-08-20 (see label) | SUPPLNDA202714 | approved | openfda |
| Aug 19, 2020 | Bevacizumab | EMA EU | cancer not stated in this record | Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/005106 | approved | ema |
| Aug 19, 2020 | Cladribine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CLADRIBINE INJECTION (DIN 02494574) under ATC L01BB04 CLADRIBINE. Indications are not published in the Drug Product… | DIN02494574 | approvedsource: Marketed | health-canada-dpd |
| Aug 12, 2020 | Daratumumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as DARZALEX SC (DIN 02502712) under ATC L01FC01 DARATUMUMAB. Indications are not published in the Drug Product Database… | DIN02502712 | approvedsource: Marketed | health-canada-dpd |
| Aug 10, 2020 | Glasdegib | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAURISMO (DIN 02498480) under ATC L01XJ03 GLASDEGIB. Indications are not published in the Drug Product Database — see… | DIN02498480 | approvedsource: Marketed | health-canada-dpd |
| Aug 10, 2020 | Glasdegib | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAURISMO (DIN 02498472) under ATC L01XJ03 GLASDEGIB. Indications are not published in the Drug Product Database — see… | DIN02498472 | approvedsource: Marketed | health-canada-dpd |
| Aug 4, 2020 | Enzalutamide | FDA US | Malignant Prostate Neoplasm | non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 ) | ORIGNDA213674 | approved | openfda |
| Aug 4, 2020 | Enzalutamide | FDA US | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer. ( 1 ) | ORIGNDA213674 | approved | openfda |
| Aug 4, 2020 | Enzalutamide | FDA US | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer. ( 1 ) | ORIGNDA213674 | approved | openfda |
| Aug 4, 2020 | Enzalutamide | FDA US | Nonmetastatic Castration-Sensitive Prostate Carcinoma | non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI… | ORIGNDA213674 | approved | openfda |
| Aug 4, 2020 | Enzalutamide | FDA US | Malignant Prostate Neoplasm | metastatic castration-sensitive prostate cancer (mCSPC) | ORIGNDA213674 | approved | openfda |
| Aug 4, 2020 | Enzalutamide | FDA US | Castration-Resistant Prostate Carcinoma | castration-resistant prostate cancer (CRPC) | ORIGNDA213674 | approved | openfda |
| approved |
| openfda |
| Jul 31, 2020 | Tafasitamab | FDA US | Follicular Lymphoma | in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). | ORIGBLA761163 | approved | openfda |