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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
183
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 48 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 12 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 |
|---|---|---|---|---|---|---|---|
| Sep 8, 2025 | Bosutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-BOSUTINIB (DIN 02560038) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product… | DIN02560038 | approvedsource: Marketed | health-canada-dpd |
| Sep 8, 2025 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02541998) under ATC L01AA09 BENDAMUSTINE. Indications are not published… | DIN02541998 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 29, 2025 | Denosumab | FDA US | cancer not stated in this record | Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is… | ORIG |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 29, 2025 | Celecoxib | FDA US | cancer not stated in this record | VYSCOXA contains celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated: In adults for • Osteoarthritis (OA) • Rheumatoid… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 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 Evfraxy significantly… |
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 |
| openfda |
| Aug 29, 2025 | Denosumab | FDA US | Multiple Myeloma | Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. | ORIGBLA761444 | approved | openfda |
| Aug 27, 2025 | Tovorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-08-27 (see label) | SUPPLNDA218033 | approved | openfda |
| Aug 27, 2025 | Tovorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-08-27 (see label) | SUPPLNDA217700 | approved | openfda |
| Aug 22, 2025 | Nintedanib | EMA EU | cancer not stated in this record | Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in… | centralisedEMEA/H/C/006486 | approved | ema |
| Aug 18, 2025 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/006739 | approved | ema |
| Aug 14, 2025 | Nirogacestat | EMA EU | cancer not stated in this record | Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment. | centralisedEMEA/H/C/006071 | approved | ema |
| Aug 14, 2025 | Retifanlimab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZYNYZ (DIN 02555239) under ATC L01FF10 RETIFANLIMAB. Indications are not published in the Drug Product Database — see… | DIN02555239 | approvedsource: Marketed | health-canada-dpd |
| Aug 14, 2025 | Lazertinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-08-14 (see label) | SUPPLNDA219008 | approved | openfda |
| Aug 14, 2025 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-08-14 (see label) | SUPPLBLA761210 | approved | openfda |
| Aug 11, 2025 | Belantamab Mafodotin | Health Canada CA | cancer not stated in this record | Marketed in Canada as BLENREP (DIN 02559625) under ATC L01FX15 BELANTAMAB MAFODOTIN. Indications are not published in the Drug Product… | DIN02559625 | approvedsource: Marketed | health-canada-dpd |
| Aug 11, 2025 | Belantamab Mafodotin | Health Canada CA | cancer not stated in this record | Marketed in Canada as BLENREP (DIN 02559617) under ATC L01FX15 BELANTAMAB MAFODOTIN. Indications are not published in the Drug Product… | DIN02559617 | approvedsource: Marketed | health-canada-dpd |
| Aug 8, 2025 | Zongertinib | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC)… | ORIGNDA219042 | approved | openfda |
| Aug 8, 2025 | Carboplatin | FDA US | Ovarian Carcinoma | As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. | ORIGNDA219921 | approved | openfda |
| Aug 8, 2025 | Carboplatin | FDA US | Ovarian Carcinoma | As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. | ORIGNDA219921 | approved | openfda |
| Aug 6, 2025 | Dordaviprone | FDA US | Diffuse Midline Glioma | MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3… | ORIGNDA219876 | approved | openfda |
| Aug 1, 2025 | Dasatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-08-01 (see label) | SUPPLNDA216099 | approved | openfda |
| ORIGNDA211759 |
| approved |
| openfda |
| Jul 24, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-07-24 (see label) | SUPPLBLA125514 | approved | openfda |
| Jul 23, 2025 | Belantamab Mafodotin | EMA EU | Multiple Myeloma | Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and… | centralisedEMEA/H/C/006511 | approved | ema |
| Jul 22, 2025 | Anastrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as AG-ANASTROZOLE TABLETS (DIN 02553686) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug… | DIN02553686 | approvedsource: Marketed | health-canada-dpd |
| Jul 21, 2025 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB INJECTION (DIN 02550075) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug Product… | DIN02550075 | approvedsource: Marketed | health-canada-dpd |
| Jul 18, 2025 | Inavolisib | EMA EU | Malignant Breast Neoplasm | Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen… | centralisedEMEA/H/C/006353 | approved | ema |
| Jul 18, 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 denosumab… | centralisedEMEA/H/C/006268 | approved | ema |
| Jul 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 denosumab… | centralisedEMEA/H/C/006507 | approved | ema |
| Jul 17, 2025 | Mirdametinib | EMA EU | cancer not stated in this record | Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult… | centralisedEMEA/H/C/006460 | approved | ema |
| Jul 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/006269 | approved | ema |
| Jul 17, 2025 | Obecabtagene Autoleucel | EMA EU | B Acute Lymphoblastic Leukemia | Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor… | centralisedEMEA/H/C/005907 | approved | ema |
| Jul 14, 2025 | Pazopanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-PAZOPANIB (DIN 02552957) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database… | DIN02552957 | approvedsource: Marketed | health-canada-dpd |
| Jul 11, 2025 | Eribulin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ERIBULIN MESYLATE INJECTION (DIN 02545950) under ATC L01XX41 ERIBULIN. Indications are not published in the Drug… | DIN02545950 | approvedsource: Marketed | health-canada-dpd |
| Jul 10, 2025 | Elranatamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-07-10 (see label) | SUPPLBLA761345 | approved | openfda |
| Jul 3, 2025 | Bendamustine | FDA US | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a… | ORIGNDA219014 | approved | openfda |
| Jul 3, 2025 | Bendamustine | FDA US | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | ORIGNDA219014 | approved | openfda |
| centralisedEMEA/H/C/006526 |
| approved |
| ema |
| Jun 30, 2025 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast… | centralisedEMEA/H/C/006219 | approved | ema |
| Jun 27, 2025 | Zanidatamab | EMA EU | Malignant Biliary Tract Neoplasm | Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+)… | centralisedEMEA/H/C/006380 | approved | ema |
| Jun 27, 2025 | Gemcitabine | FDA US | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | ORIGNDA219920 | approved | openfda |
| Jun 27, 2025 | Gemcitabine | FDA US | Lung Non-Small Cell Carcinoma | in combination with cisplatin, for the treatment of non-small cell lung cancer. | ORIGNDA219920 | approved | openfda |
| Jun 27, 2025 | Gemcitabine | FDA US | Malignant Breast Neoplasm | in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing… | ORIGNDA219920 | approved | openfda |
| Jun 27, 2025 | Gemcitabine | FDA US | Malignant Ovarian Neoplasm | in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of… | ORIGNDA219920 | approved | openfda |
| Jun 26, 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, denosumab… | centralisedEMEA/H/C/006377 | approved | ema |
| Jun 26, 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/006376 | approved | ema |
| Jun 26, 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/006199 | approved | ema |
| Jun 26, 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, denosumab… | centralisedEMEA/H/C/006152 | approved | ema |
| Jun 25, 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/006534 | approved | ema |
| Jun 25, 2025 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEPADINA (DIN 02523906) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug Product Database — see… | DIN02523906 | withdrawnsource: Dormantsince Jul 31, 2026 | health-canada-dpd |
| Jun 23, 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/006437 | approved | ema |
| Jun 23, 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 Junod significantly… | centralisedEMEA/H/C/006436 | approved | ema |