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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
4,340
Distinct drugs
372
Records naming a cancer
982
Dated in the last 12 months
182
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 49 | Sep 22, 2026 |
| EMA | EU | 459 | 245 | 385 | 74 | 18 | Jul 20, 2026 |
Data updated 18 hours agoSource 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 |
|---|---|---|---|---|---|---|---|
| May 29, 2026 | Nilotinib | FDA US | cancer not stated in this record | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | ORIGNDA217379 | approved | openfda |
| May 29, 2026 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included… | ORIGNDA217379 | approved | openfda |
| May 28, 2026 | Nadofaragene Firadenovec | EMA EU | Non-Muscle Invasive Bladder Carcinoma | Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle… | centralisedEMEA/H/C/005856 | approved | ema |
| May 28, 2026 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-28 (see label) | SUPPLBLA761069 | approved | openfda |
| May 22, 2026 | Datopotamab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-22 (see label) | SUPPLBLA761394 | approved | openfda |
| May 20, 2026 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-20 (see label) | SUPPLNDA208573 | approved | openfda |
| May 18, 2026 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-18 (see label) | SUPPLBLA761334 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761139 | approved | openfda |
| May 15, 2026 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-05-15 (see label) | SUPPLBLA761034 | approved | openfda |
| May 5, 2026 | Mosunetuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUNSUMIO (DIN 02565226) under ATC L01FX25 MOSUNETUZUMAB. Indications are not published in the Drug Product Database —… | DIN02565226 | approvedsource: Marketed | health-canada-dpd |
| May 1, 2026 | Trabectedin | FDA US | cancer not stated in this record | EVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior… | ORIGNDA220837 | approved | openfda |
| May 1, 2026 | Ruxolitinib | FDA US | cancer not stated in this record | intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential… | ORIGNDA217180 | approved | openfda |
| May 1, 2026 | Ruxolitinib | FDA US | Polycythemia Vera | polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. | ORIGNDA217180 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 27, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 30, 2026 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-30 (see label) | SUPPLBLA761334 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 26, 2026 | Zongertinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-26 (see label) | SUPPLNDA219042 | 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.
| Apr 27, 2026 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Apr 24, 2026 | Sevabertinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as HYRNUO (DIN 02563444) under ATC L01EH06 SEVABERTINIB. Indications are not published in the Drug Product Database —… | DIN02563444 | approvedsource: Marketed | health-canada-dpd |
| Apr 23, 2026 | Pertuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult… | centralisedEMEA/H/C/006583 | approved | ema |
| Apr 23, 2026 | Selinexor | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-23 (see label) | SUPPLNDA212306 | approved | openfda |
| Apr 23, 2026 | Pertuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-23 (see label) | SUPPLBLA125409 | approved | openfda |
| Apr 20, 2026 | Tovorafenib | EMA EU | cancer not stated in this record | Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG)… | centralisedEMEA/H/C/006140 | approved | ema |
| Apr 15, 2026 | Inavolisib | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-15 (see label) | SUPPLNDA219249 | approved | openfda |
| Apr 9, 2026 | Azacitidine | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-09 (see label) | SUPPLNDA214120 | approved | openfda |
| Apr 2, 2026 | Aflibercept | FDA US | cancer not stated in this record | Efficacy supplement 2026-04-02 (see label) | SUPPLBLA761355 | approved | openfda |
| Apr 1, 2026 | Tislelizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVIMBRA (DIN 02564009) under ATC L01FF09 TISLELIZUMAB. Indications are not published in the Drug Product Database —… | DIN02564009 | approvedsource: Marketed | health-canada-dpd |
| Mar 30, 2026 | Enzalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-ENZALUTAMIDE (DIN 02562677) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product… | DIN02562677 | approvedsource: Marketed | health-canada-dpd |
| Mar 30, 2026 | Enzalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-ENZALUTAMIDE (DIN 02558424) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product… | DIN02558424 | approvedsource: Marketed | health-canada-dpd |
| Mar 30, 2026 | Quizartinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VANFLYTA (DIN 02558378) under ATC L01EX11 QUIZARTINIB. Indications are not published in the Drug Product Database —… | DIN02558378 | approvedsource: Marketed | health-canada-dpd |
| Mar 30, 2026 | Enzalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-ENZALUTAMIDE (DIN 02494736) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product… | DIN02494736 | approvedsource: Marketed | health-canada-dpd |
| Mar 27, 2026 | Epcoritamab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-27 (see label) | SUPPLBLA761324 | approved | openfda |
| Mar 20, 2026 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-20 (see label) | SUPPLBLA125554 | approved | openfda |
| Mar 6, 2026 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-06 (see label) | SUPPLNDA213082 | approved | openfda |
| Mar 6, 2026 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-06 (see label) | SUPPLNDA208246 | approved | openfda |
| Mar 6, 2026 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-06 (see label) | SUPPLNDA203214 | approved | openfda |
| Mar 5, 2026 | Teclistamab | FDA US | cancer not stated in this record | Efficacy supplement 2026-03-05 (see label) | SUPPLBLA761291 | approved | openfda |
| Mar 5, 2026 | Pembrolizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as KEYTRUDA SC (DIN 02565382) under ATC L01FF02 PEMBROLIZUMAB. Indications are not published in the Drug Product… | DIN02565382 | approvedsource: Marketed | health-canada-dpd |
| Feb 24, 2026 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-24 (see label) | SUPPLNDA210496 | approved | openfda |
| Feb 24, 2026 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-24 (see label) | SUPPLNDA210496 | approved | openfda |
| Feb 20, 2026 | Enzalutamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP ENZALUTAMIDE (DIN 02515229) under ATC L02BB04 ENZALUTAMIDE. Indications are not published in the Drug Product… | DIN02515229 | approvedsource: Marketed | health-canada-dpd |
| Feb 20, 2026 | Fluorouracil | FDA US | Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ORIGNDA220201 | approved | openfda |
| Feb 20, 2026 | Fluorouracil | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma | ORIGNDA220201 | approved | openfda |
| Feb 20, 2026 | Fluorouracil | FDA US | Breast Adenocarcinoma | Adenocarcinoma of the Breast | ORIGNDA220201 | approved | openfda |
| Feb 20, 2026 | Fluorouracil | FDA US | Colon Adenocarcinoma | FAVLYXA is a nucleoside metabolic inhibitor indicated for the treatment of patients with: Adenocarcinoma of the Colon and Rectum | ORIGNDA220201 | approved | openfda |
| Feb 19, 2026 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-19 (see label) | SUPPLNDA210259 | approved | openfda |
| Feb 19, 2026 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-19 (see label) | SUPPLNDA216387 | approved | openfda |
| Feb 19, 2026 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-19 (see label) | SUPPLNDA208573 | approved | openfda |