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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Feb 16, 2026 | Nogapendekin Alfa Inbakicept | EMA EU | Non-Muscle Invasive Bladder Carcinoma | Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive… | centralisedEMEA/H/C/006622 | approved | ema |
| Feb 13, 2026 | Etoposide | FDA US | Lung Small Cell Carcinoma | Small cell lung cancer | ORIGNDA220200 | approved | openfda |
| Feb 13, 2026 | Etoposide | FDA US | Malignant Testicular Neoplasm | Refractory testicular cancer | ORIGNDA220200 | approved | openfda |
| Feb 12, 2026 | Aumolertinib | EMA EU | Lung Non-Small Cell Carcinoma | Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose… | centralisedEMEA/H/C/006069 | approved | ema |
| Feb 10, 2026 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2026-02-10 (see label) | SUPPLBLA125514 | approved | openfda |
| Feb 3, 2026 | Leucovorin | FDA US | cancer not stated in this record | Reducing the toxicity of methotrexate in adult and pediatric patients with impaired methotrexate elimination or folic acid antagonists or… | ORIGNDA220406 | approved | openfda |
| Feb 3, 2026 | Leucovorin | FDA US | Malignant Colorectal Neoplasm | Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil. | ORIGNDA220406 | approved | openfda |
| Feb 3, 2026 | Leucovorin | FDA US | Malignant Colorectal Neoplasm | Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and… | ORIGNDA220406 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 28, 2026 | Leuprolide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUPRON DEPOT (DIN 02562855) under ATC L02AE02 LEUPRORELIN. Indications are not published in the Drug Product Database… | DIN02562855 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 30, 2025 | Nivolumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as OPDIVO SC (DIN 02557320) under ATC L01FF01 NIVOLUMAB. Indications are not published in the Drug Product Database —… | DIN02557320 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 28, 2025 | Pirtobrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAYPIRCA (DIN 02562014) under ATC L01EL05 PIRTOBRUTINIB. Indications are not published in the Drug Product Database —… | DIN02562014 |
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.
| approvedsource: Marketed |
| health-canada-dpd |
| Jan 26, 2026 | Toripalimab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LOQTORZI (DIN 02562219) under ATC L01FF13 TORIPALIMAB. Indications are not published in the Drug Product Database —… | DIN02562219 | approvedsource: Marketed | health-canada-dpd |
| Jan 23, 2026 | Ibuprofen | FDA US | cancer not stated in this record | Efficacy supplement 2026-01-23 (see label) | SUPPLNDA022348 | approved | openfda |
| Jan 9, 2026 | Imlunestrant | EMA EU | Malignant Breast Neoplasm | Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally… | centralisedEMEA/H/C/006184 | approved | ema |
| Jan 9, 2026 | Mirvetuximab Soravtansine | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELAHERE (DIN 02560771) under ATC L01FX26 MIRVETUXIMAB SORAVTANSINE. Indications are not published in the Drug Product… | DIN02560771 | approvedsource: Marketed | health-canada-dpd |
| Jan 8, 2026 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… | centralisedEMEA/H/C/006492 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Dec 22, 2025 | Nintedanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP NINTEDANIB (DIN 02550849) under ATC L01EX09 NINTEDANIB. Indications are not published in the Drug Product… | DIN02550849 | approvedsource: Marketed | health-canada-dpd |
| Dec 22, 2025 | Nintedanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP NINTEDANIB (DIN 02540762) under ATC L01EX09 NINTEDANIB. Indications are not published in the Drug Product… | DIN02540762 | approvedsource: Marketed | health-canada-dpd |
| Dec 22, 2025 | Nintedanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-NINTEDANIB (DIN 02526905) under ATC L01EX09 NINTEDANIB. Indications are not published in the Drug Product… | DIN02526905 | approvedsource: Marketed | health-canada-dpd |
| Dec 22, 2025 | Nintedanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-NINTEDANIB (DIN 02526891) under ATC L01EX09 NINTEDANIB. Indications are not published in the Drug Product… | DIN02526891 | approvedsource: Marketed | health-canada-dpd |
| Dec 19, 2025 | Mosunetuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-19 (see label) | SUPPLBLA761263 | approved | openfda |
| Dec 17, 2025 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-17 (see label) | SUPPLBLA761334 | approved | openfda |
| Dec 17, 2025 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-17 (see label) | SUPPLNDA209115 | approved | openfda |
| Dec 17, 2025 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-17 (see label) | SUPPLNDA209115 | approved | openfda |
| Dec 15, 2025 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-15 (see label) | SUPPLBLA761139 | approved | openfda |
| Dec 15, 2025 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-15 (see label) | SUPPLBLA761139 | approved | openfda |
| Dec 9, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-09 (see label) | SUPPLBLA761232 | approved | openfda |
| Dec 9, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-09 (see label) | SUPPLBLA761232 | approved | openfda |
| Dec 9, 2025 | Tislelizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-09 (see label) | SUPPLBLA761232 | approved | openfda |
| Dec 2, 2025 | Pirtobrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-02 (see label) | SUPPLNDA216059 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 28, 2025 | Pirtobrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAYPIRCA (DIN 02562006) under ATC L01EL05 PIRTOBRUTINIB. Indications are not published in the Drug Product Database —… | DIN02562006 | approvedsource: Marketed | health-canada-dpd |
| Nov 28, 2025 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-METHOTREXATE TABLETS (DIN 02561956) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02561956 | approvedsource: Marketed | health-canada-dpd |
| Nov 26, 2025 | Treosulfan | Health Canada CA | cancer not stated in this record | Marketed in Canada as TREOSULFAN FOR INJECTION (DIN 02560585) under ATC L01AB02 TREOSULFAN. Indications are not published in the Drug… | DIN02560585 | approvedsource: Marketed | health-canada-dpd |
| Nov 25, 2025 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-25 (see label) | SUPPLBLA761069 | approved | openfda |
| Nov 25, 2025 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-25 (see label) | SUPPLNDA215358 | approved | openfda |
| Nov 21, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-21 (see label) | SUPPLBLA125514 | approved | openfda |
| Nov 21, 2025 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-21 (see label) | SUPPLBLA761137 | approved | openfda |
| Nov 20, 2025 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-20 (see label) | SUPPLNDA213246 | approved | openfda |
| Nov 20, 2025 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-20 (see label) | SUPPLNDA218160 | approved | openfda |
| Nov 19, 2025 | Tarlatamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-19 (see label) | SUPPLBLA761344 | approved | openfda |
| Nov 19, 2025 | Aflibercept | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-19 (see label) | SUPPLBLA761355 | approved | openfda |
| Nov 19, 2025 | Sevabertinib | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)… | ORIGNDA219972 | approved | openfda |
| Nov 19, 2025 | Selumetinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-19 (see label) | SUPPLNDA213756 | approved | openfda |
| Nov 18, 2025 | Epcoritamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-11-18 (see label) | SUPPLBLA761324 | approved | openfda |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra significantly… | centralisedEMEA/H/C/006734 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006722 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006552 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis… | centralisedEMEA/H/C/006490 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006239 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Ponlimsi significantly… | centralisedEMEA/H/C/006238 | approved | ema |