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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 1 hour 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 30, 2025 | Quizartinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VANFLYTA (DIN 02558351) under ATC L01EX11 QUIZARTINIB. Indications are not published in the Drug Product Database —… | DIN02558351 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 2025 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02558971) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN |
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 |
| 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… | ORIGBLA761444 | 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 |
| 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 | ORIGBLA761392 | approved | openfda |
| Oct 29, 2025 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-29 (see label) | SUPPLBLA761097 | approved | openfda |
| Oct 24, 2025 | Revumenib | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-24 (see label) | SUPPLNDA218944 | approved | openfda |
| Oct 23, 2025 | Belantamab Mafodotin | FDA US | Multiple Myeloma | BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory… | ORIGBLA761440 | approved | openfda |
| Oct 17, 2025 | Obinutuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-17 (see label) | SUPPLBLA125486 | approved | openfda |
| Oct 17, 2025 | Obinutuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-17 (see label) | SUPPLBLA125486 | approved | openfda |
| Oct 16, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-16 (see label) | SUPPLNDA213082 | approved | openfda |
| Oct 16, 2025 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-16 (see label) | SUPPLNDA203214 | approved | openfda |
| Oct 14, 2025 | Sotorasib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUMAKRAS (DIN 02552655) under ATC L01XX73 SOTORASIB. Indications are not published in the Drug Product Database — see… | DIN02552655 | approvedsource: Marketed | health-canada-dpd |
| Oct 10, 2025 | Ponatinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-10 (see label) | SUPPLNDA203469 | approved | openfda |
| Oct 8, 2025 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-08 (see label) | SUPPLBLA761097 | approved | openfda |
| Oct 4, 2025 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-04 (see label) | SUPPLNDA215985 | approved | openfda |
| Oct 3, 2025 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-03 (see label) | SUPPLNDA210661 | approved | openfda |
| Oct 2, 2025 | Lurbinectedin | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-02 (see label) | SUPPLNDA213702 | approved | openfda |
| Oct 2, 2025 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-02 (see label) | SUPPLBLA761034 | approved | openfda |
| Oct 2, 2025 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2025-10-02 (see label) | SUPPLNDA215358 | approved | openfda |
| Oct 1, 2025 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PRZ-ABIRATERONE (DIN 02540460) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02540460 | approvedsource: Marketed | health-canada-dpd |
| Oct 1, 2025 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as PRZ-ABIRATERONE (DIN 02540452) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02540452 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Sep 30, 2025 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-SUNITINIB (DIN 02552892) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02552892 | approvedsource: Marketed | health-canada-dpd |
| Sep 30, 2025 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-SUNITINIB (DIN 02552906) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02552906 | approvedsource: Marketed | health-canada-dpd |
| Sep 30, 2025 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-SUNITINIB (DIN 02539284) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02539284 | approvedsource: Marketed | health-canada-dpd |
| Sep 29, 2025 | Anastrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP ANASTROZOLE TABLETS (DIN 02540584) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug… | DIN02540584 | approvedsource: Marketed | health-canada-dpd |
| Sep 25, 2025 | Imlunestrant | FDA US | Malignant Breast Neoplasm | INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2… | ORIGNDA218881 | approved | openfda |
| Sep 18, 2025 | Ruxolitinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-09-18 (see label) | SUPPLNDA215309 | approved | openfda |
| Sep 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/006435 | approved | ema |
| Sep 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. Inpostmenopausal women, denosumab… | centralisedEMEA/H/C/006434 | approved | ema |
| Sep 17, 2025 | Vimseltinib | EMA EU | cancer not stated in this record | Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically… | centralisedEMEA/H/C/006363 | approved | ema |
| Sep 17, 2025 | Vorasidenib | EMA EU | Grade 2 Follicular Lymphoma | Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an… | centralisedEMEA/H/C/006284 | approved | ema |
| Sep 16, 2025 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as FILRA (DIN 02556545) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database — see… | DIN02556545 | approvedsource: Marketed | health-canada-dpd |
| Sep 16, 2025 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as FILRA (DIN 02556537) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database — see… | DIN02556537 | approvedsource: Marketed | health-canada-dpd |
| Sep 16, 2025 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2025-09-16 (see label) | SUPPLNDA212436 | approved | openfda |
| Sep 16, 2025 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2025-09-16 (see label) | SUPPLNDA207103 | approved | openfda |
| Sep 10, 2025 | Selumetinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-09-10 (see label) | SUPPLNDA213756 | approved | openfda |
| Sep 10, 2025 | Selumetinib | FDA US | cancer not stated in this record | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who… | ORIGNDA219943 | approved | openfda |
| Sep 10, 2025 | Cabozantinib | FDA US | cancer not stated in this record | Efficacy supplement 2025-09-10 (see label) | SUPPLNDA208692 | approved | openfda |
| Sep 9, 2025 | Gemcitabine | FDA US | Non-Muscle Invasive Bladder Carcinoma | INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder… | ORIGNDA219683 | approved | openfda |
| Sep 9, 2025 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEXEGRA (DIN 02553945) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02553945 | approvedsource: Marketed | health-canada-dpd |
| Sep 8, 2025 | Bosutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-BOSUTINIB (DIN 02560046) under ATC L01EA04 BOSUTINIB. Indications are not published in the Drug Product… | DIN02560046 | approvedsource: Marketed | health-canada-dpd |