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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 16 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 14, 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/006157 | approved | ema |
| Feb 14, 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/006156 | approved | ema |
| Feb 13, 2025 | Denosumab | FDA US | cancer not stated in this record | of postmenopausal women with osteoporosis at high risk for fracture • to increase bone mass in men with osteoporosis at high risk for… | ORIGBLA761392 | approved | openfda |
| Feb 13, 2025 | Denosumab | FDA US | Malignant Breast Neoplasm | to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer | ORIGBLA761392 | approved | openfda |
| Feb 13, 2025 | Denosumab | FDA US | Malignant Prostate Neoplasm | to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer | ORIGBLA761392 | approved | openfda |
| Feb 13, 2025 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-NILOTINIB (DIN 02550903) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database… | DIN02550903 | approvedsource: Marketed | health-canada-dpd |
| Feb 13, 2025 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-NILOTINIB (DIN 02550881) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database… | DIN02550881 | approvedsource: Marketed | health-canada-dpd |
| Feb 12, 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/006468 | approved | ema |
| Feb 12, 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/006424 | approved | ema |
| Feb 12, 2025 | Filgrastim | EMA EU | cancer not stated in this record | Zefylti is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with… | centralisedEMEA/H/C/006400 | approved | ema |
| Feb 12, 2025 | Belzutifan | EMA EU | cancer not stated in this record | Renal cell carcinoma (RCC) Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell… | centralisedEMEA/H/C/005636 | approved | ema |
| Feb 12, 2025 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIOPEG (DIN 02546973) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02546973 | approvedsource: Marketed | health-canada-dpd |
| Feb 11, 2025 | Brentuximab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-11 (see label) | SUPPLBLA125388 | approved | openfda |
| Feb 10, 2025 | Catumaxomab | EMA EU | cancer not stated in this record | Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule… | centralisedEMEA/H/C/005697 | approved | ema |
| Feb 3, 2025 | Serplulimab | EMA EU | cancer not stated in this record | Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult… | centralisedEMEA/H/C/006170 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2025 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MAR-AFATINIB (DIN 02517035) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database —… | DIN02517035 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 23, 2024 | Hydroxyurea | FDA US | cancer not stated in this record | XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 28, 2024 | Tarlatamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMDELLTRA (DIN 02551578) under ATC L01FX33 TARLATAMAB. Indications are not published in the Drug Product Database —… | DIN02551578 |
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 31, 2025 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MAR-AFATINIB (DIN 02517027) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database —… | DIN02517027 | approvedsource: Marketed | health-canada-dpd |
| Jan 31, 2025 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as MAR-AFATINIB (DIN 02517019) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database —… | DIN02517019 | approvedsource: Marketed | health-canada-dpd |
| Jan 29, 2025 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-29 (see label) | SUPPLNDA206947 | approved | openfda |
| Jan 28, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Jan 28, 2025 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-28 (see label) | SUPPLBLA125377 | approved | openfda |
| Jan 27, 2025 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Jan 27, 2025 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-27 (see label) | SUPPLBLA761139 | approved | openfda |
| Jan 27, 2025 | Ramucirumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-27 (see label) | SUPPLBLA125477 | approved | openfda |
| Jan 23, 2025 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-23 (see label) | SUPPLBLA761036 | approved | openfda |
| Jan 21, 2025 | Treosulfan | FDA US | Myelodysplastic Syndrome | . Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and… | ORIGNDA214759 | approved | openfda |
| Jan 21, 2025 | Treosulfan | FDA US | Acute Myeloid Leukemia | Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and… | ORIGNDA214759 | approved | openfda |
| Jan 21, 2025 | Momelotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as OJJAARA (DIN 02552981) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database —… | DIN02552981 | approvedsource: Marketed | health-canada-dpd |
| Jan 21, 2025 | Momelotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as OJJAARA (DIN 02552973) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database —… | DIN02552973 | approvedsource: Marketed | health-canada-dpd |
| Jan 21, 2025 | Momelotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as OJJAARA (DIN 02552965) under ATC L01EJ04 MOMELOTINIB. Indications are not published in the Drug Product Database —… | DIN02552965 | approvedsource: Marketed | health-canada-dpd |
| Jan 20, 2025 | Lazertinib | EMA EU | Lung Non-Small Cell Carcinoma | Lazcluze in combination with amivantamab is indicated for the first line treatment of adult patients with advanced non small cell lung… | centralisedEMEA/H/C/006074 | approved | ema |
| Jan 17, 2025 | Datopotamab Deruxtecan | FDA US | Malignant Breast Neoplasm | adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative… | ORIGBLA761394 | approved | openfda |
| Jan 17, 2025 | Datopotamab Deruxtecan | FDA US | Triple-Negative Breast Carcinoma | This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies… | ORIGBLA761394 | approved | openfda |
| Jan 17, 2025 | Datopotamab Deruxtecan | FDA US | Lung Non-Small Cell Carcinoma with EGFR Mutation | adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who… | ORIGBLA761394 | approved | openfda |
| Jan 16, 2025 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-16 (see label) | SUPPLNDA210259 | approved | openfda |
| Jan 16, 2025 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-16 (see label) | SUPPLNDA216387 | approved | openfda |
| Jan 16, 2025 | Sotorasib | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-16 (see label) | SUPPLNDA214665 | approved | openfda |
| Jan 16, 2025 | Panitumumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-16 (see label) | SUPPLBLA125147 | approved | openfda |
| Jan 13, 2025 | Repotrectinib | EMA EU | Tumor-agnosticLung Non-Small Cell Carcinoma | Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).… | centralisedEMEA/H/C/006005 | approved | ema |
| ORIGNDA216593 |
| approved |
| openfda |
| Dec 20, 2024 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2024-12-20 (see label) | SUPPLNDA210496 | approved | openfda |
| Dec 18, 2024 | Ensartinib | FDA US | cancer not stated in this record | ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic… | ORIGNDA218171 | approved | openfda |
| Dec 11, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-12-11 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 4, 2024 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-12-04 (see label) | SUPPLBLA761069 | approved | openfda |
| Dec 2, 2024 | Avapritinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYVAKYT (DIN 02551799) under ATC L01EX18 AVAPRITINIB. Indications are not published in the Drug Product Database —… | DIN02551799 | approvedsource: Marketed | health-canada-dpd |
| Dec 2, 2024 | Avapritinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYVAKYT (DIN 02551780) under ATC L01EX18 AVAPRITINIB. Indications are not published in the Drug Product Database —… | DIN02551780 | approvedsource: Marketed | health-canada-dpd |
| Dec 2, 2024 | Avapritinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYVAKYT (DIN 02551772) under ATC L01EX18 AVAPRITINIB. Indications are not published in the Drug Product Database —… | DIN02551772 | approvedsource: Marketed | health-canada-dpd |
| Dec 2, 2024 | Avapritinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AYVAKYT (DIN 02551764) under ATC L01EX18 AVAPRITINIB. Indications are not published in the Drug Product Database —… | DIN02551764 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 28, 2024 | Tarlatamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as IMDELLTRA (DIN 02551551) under ATC L01FX33 TARLATAMAB. Indications are not published in the Drug Product Database —… | DIN02551551 | approvedsource: Marketed | health-canada-dpd |