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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
179
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 44 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 19 hours 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 |
|---|---|---|---|---|---|---|---|
| Mar 25, 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 | ORIGBLA761398 | approved | openfda |
| Mar 19, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-19 (see label) | SUPPLBLA125514 | approved | openfda |
| Mar 12, 2025 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-12 (see label) | SUPPLNDA210496 | approved | openfda |
| Mar 12, 2025 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-12 (see label) | SUPPLNDA210498 | approved | openfda |
| Mar 7, 2025 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA217513 | approved | openfda |
| Mar 7, 2025 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA204114 | approved | openfda |
| Mar 7, 2025 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA202806 | approved | openfda |
| Mar 7, 2025 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-03-07 (see label) | SUPPLNDA217514 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 28, 2025 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-28 (see label) | SUPPLBLA761069 | approved | openfda |
| Feb 21, 2025 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 29, 2025 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-01-29 (see label) | SUPPLNDA206947 | approved | openfda |
| 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 22, 2024 | Mosunetuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761263 | 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.
| Tofacitinib |
| FDA US |
| cancer not stated in this record |
| Efficacy supplement 2025-02-21 (see label) |
| SUPPLNDA213082 |
| approved |
| openfda |
| Feb 21, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-21 (see label) | SUPPLNDA208246 | approved | openfda |
| Feb 21, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-21 (see label) | SUPPLNDA203214 | approved | openfda |
| Feb 19, 2025 | 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. | ORIGNDA218922 | approved | openfda |
| Feb 19, 2025 | 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… | ORIGNDA218922 | approved | openfda |
| Feb 14, 2025 | Vimseltinib | FDA US | cancer not stated in this record | ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection… | ORIGNDA219304 | approved | openfda |
| 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 11, 2025 | Brentuximab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2025-02-11 (see label) | SUPPLBLA125388 | 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 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 |
| 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 |
| Nov 22, 2024 | Teclistamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761291 | approved | openfda |
| Nov 22, 2024 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761115 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | cancer not stated in this record | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. •… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR)… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | ORIGNDA219097 | approved | openfda |