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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Jul 31, 2020 | Tafasitamab | FDA US | Diffuse Large B-Cell Lymphoma | in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not… | ORIGBLA761163 | approved | openfda |
| Jul 31, 2020 | Entrectinib | EMA EU | Tumor-agnosticLung Non-Small Cell Carcinoma | Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours… | centralisedEMEA/H/C/004936 | approved | ema |
| Jul 30, 2020 | Cyclophosphamide | FDA US | cancer not stated in this record | Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant… | ORIGNDA212501 | approved | openfda |
| Jul 30, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-07-30 (see label) | SUPPLBLA761034 | approved | openfda |
| Jul 29, 2020 | Neratinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-07-29 (see label) | SUPPLNDA208051 | approved | openfda |
| Jul 28, 2020 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2020-07-28 (see label) | SUPPLNDA021344 | approved | openfda |
| Jul 27, 2020 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast… | centralised | ||
| Jul 27, 2020 | Alpelisib | EMA EU | Malignant Breast Neoplasm | Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor… | centralisedEMEA/H/C/004804 | approved | ema |
| Jul 6, 2020 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2020-07-06 (see label) | SUPPLNDA209092 | approved | openfda |
| Jul 3, 2020 | Isatuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as SARCLISA (DIN 02498243) under ATC L01FC02 ISATUXIMAB. Indications are not published in the Drug Product Database —… | DIN02498243 | approvedsource: Marketed | health-canada-dpd |
| Jul 3, 2020 | Isatuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as SARCLISA (DIN 02498235) under ATC L01FC02 ISATUXIMAB. Indications are not published in the Drug Product Database —… | DIN02498235 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 2020 | Isatuximab | EMA EU | Multiple Myeloma | Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and… |
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.
| approved |
| ema |
| Jun 29, 2020 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-29 (see label) | SUPPLBLA761036 | approved | openfda |
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497085) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497085 | approvedsource: Marketed | health-canada-dpd |
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497077) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497077 | approvedsource: Marketed | health-canada-dpd |
| Jun 29, 2020 | Alpelisib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PIQRAY (DIN 02497069) under ATC L01EM03 ALPELISIB. Indications are not published in the Drug Product Database — see… | DIN02497069 | approvedsource: Marketed | health-canada-dpd |
| Jun 29, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-29 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 26, 2020 | Glasdegib | EMA EU | Secondary Acute Myeloid Leukemia | Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid… | centralisedEMEA/H/C/004878 | approved | ema |
| Jun 25, 2020 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-25 (see label) | SUPPLBLA761097 | approved | openfda |
| Jun 24, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-24 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 24, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-24 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 23, 2020 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02467003) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02467003 | approvedsource: Marketed | health-canada-dpd |
| Jun 22, 2020 | Selinexor | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-22 (see label) | SUPPLNDA212306 | approved | openfda |
| Jun 19, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-IMATINIB (DIN 02492342) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02492342 | approvedsource: Marketed | health-canada-dpd |
| Jun 19, 2020 | Imatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINT-IMATINIB (DIN 02492334) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database —… | DIN02492334 | approvedsource: Marketed | health-canada-dpd |
| Jun 16, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-16 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 16, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-16 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 16, 2020 | Gemtuzumab Ozogamicin | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-16 (see label) | SUPPLBLA761060 | approved | openfda |
| Jun 15, 2020 | Lurbinectedin | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this… | ORIGNDA213702 | approved | openfda |
| Jun 15, 2020 | Lurbinectedin | FDA US | Lung Small Cell Carcinoma | For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based… | ORIGNDA213702 | approved | openfda |
| Jun 15, 2020 | Lurbinectedin | FDA US | Lung Small Cell Carcinoma | in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with… | ORIGNDA213702 | approved | openfda |
| Jun 10, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485656) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485656 | approvedsource: Marketed | health-canada-dpd |
| Jun 10, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485591) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485591 | approvedsource: Marketed | health-canada-dpd |
| Jun 10, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-10 (see label) | SUPPLBLA125554 | approved | openfda |
| Jun 9, 2020 | Denosumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-09 (see label) | SUPPLBLA125320 | approved | openfda |
| Jun 9, 2020 | Olaratumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LARTRUVO (DIN 02480271) under ATC L01FX10 OLARATUMAB. Indications are not published in the Drug Product Database —… | DIN02480271 | withdrawnsource: Cancelled Post Marketsince Sep 25, 2020 | health-canada-dpd |
| Jun 4, 2020 | Axitinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-06-04 (see label) | SUPPLNDA202324 | approved | openfda |
| Jun 1, 2020 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02495635) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02495635 | approvedsource: Marketed | health-canada-dpd |
| centralisedEMEA/H/C/004977 |
| approved |
| ema |
| May 29, 2020 | Ramucirumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-29 (see label) | SUPPLBLA125477 | approved | openfda |
| May 29, 2020 | Bevacizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-29 (see label) | SUPPLBLA125085 | approved | openfda |
| May 29, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-29 (see label) | SUPPLBLA761034 | approved | openfda |
| May 26, 2020 | Interferon Beta-1a | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-26 (see label) | SUPPLBLA103780 | approved | openfda |
| May 26, 2020 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RUXIENCE (DIN 02495724) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02495724 | approvedsource: Marketed | health-canada-dpd |
| May 26, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-26 (see label) | SUPPLBLA125554 | approved | openfda |
| May 26, 2020 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-26 (see label) | SUPPLBLA125377 | approved | openfda |
| May 23, 2020 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-23 (see label) | SUPPLNDA208065 | approved | openfda |
| May 23, 2020 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-23 (see label) | SUPPLNDA208065 | approved | openfda |
| May 22, 2020 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as RIXIMYO (DIN 02498316) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02498316 | approvedsource: Marketed | health-canada-dpd |
| May 22, 2020 | Brigatinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-22 (see label) | SUPPLNDA208772 | approved | openfda |