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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 8 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 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 |
| 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 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 19, 2025 | Mosunetuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-12-19 (see label) | SUPPLBLA761263 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 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 |
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.
| 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 | 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 |
| 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 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 |
| 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 |
| 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 13, 2025 | Ziftomenib | FDA US | Acute Myeloid Leukemia | KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible… | ORIGNDA220305 | approved | openfda |
| approved |
| openfda |
| Oct 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 |
| Oct 29, 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… | ORIGBLA761398 | approved | openfda |
| Oct 29, 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 | ORIGBLA761398 | approved | openfda |
| Oct 29, 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 |
| Oct 29, 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 |
| Oct 29, 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 |