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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 6 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 |
|---|---|---|---|---|---|---|---|
| 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 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 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| 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 27, 2025 | Gemcitabine | FDA US | Malignant Pancreatic Neoplasm | as a single agent for the treatment of pancreatic cancer. | ORIGNDA219920 | 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.
| 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 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 |
| 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 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 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 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 |
| 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 18, 2025 | Tafasitamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-18 (see label) | SUPPLBLA761163 | approved | openfda |
| Jun 18, 2025 | Niraparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-18 (see label) | SUPPLNDA214876 | approved | openfda |
| Jun 12, 2025 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLNDA211651 | approved | openfda |
| Jun 12, 2025 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLNDA217439 | approved | openfda |
| Jun 12, 2025 | Mitomycin | FDA US | Non-Muscle Invasive Bladder Carcinoma | ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer… | ORIGNDA215793 | approved | openfda |
| Jun 12, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 11, 2025 | Taletrectinib | FDA US | ROS1-Positive Lung Non-Small Cell Carcinoma | IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small… | ORIGNDA219713 | approved | openfda |