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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 21 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 |
|---|---|---|---|---|---|---|---|
| Apr 5, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761139 | approved | openfda |
| Apr 4, 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… | ORIGNDA216593 | approved | openfda |
| Apr 3, 2024 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-03 (see label) | SUPPLNDA206947 | approved | openfda |
| Apr 1, 2024 | Capivasertib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUQAP (DIN 02544741) under ATC L01EX27 CAPIVASERTIB. Indications are not published in the Drug Product Database —… | DIN02544741 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 27, 2024 | Mogamulizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as POTELIGEO (DIN 02527715) under ATC L01FX09 MOGAMULIZUMAB. Indications are not published in the Drug Product Database… | DIN02527715 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 28, 2024 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE INJECTION (DIN 02528789) under ATC L01CE02 IRINOTECAN. Indications are not published in the… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2024 | Daunorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE INJECTION (DIN 02539209) under ATC L01DB02 DAUNORUBICIN. Indications are not published in… | 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 |
| Mar 22, 2024 | Mirvetuximab Soravtansine | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-22 (see label) | SUPPLBLA761310 | approved | openfda |
| Mar 19, 2024 | Ponatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-19 (see label) | SUPPLNDA203469 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | cancer not stated in this record | Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Adenocarcinoma | Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Squamous Cell Carcinoma | as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Squamous Cell Carcinoma | Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or… | ORIGBLA761232 | approved | openfda |
| Mar 7, 2024 | Zanubrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-07 (see label) | SUPPLNDA213217 | approved | openfda |
| Mar 7, 2024 | Vandetanib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-07 (see label) | SUPPLNDA022405 | approved | openfda |
| Mar 7, 2024 | Talazoparib | FDA US | Castration-Resistant Prostate Carcinoma | HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic… | ORIGNDA217439 | approved | openfda |
| Mar 7, 2024 | Talazoparib | FDA US | Malignant Breast Neoplasm | Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g… | ORIGNDA217439 | approved | openfda |
| Mar 6, 2024 | Inotuzumab Ozogamicin | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-06 (see label) | SUPPLBLA761040 | approved | openfda |
| Mar 6, 2024 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-06 (see label) | SUPPLBLA125554 | approved | openfda |
| Mar 5, 2024 | 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… | ORIGBLA761362 | approved | openfda |
| Mar 5, 2024 | 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. | ORIGBLA761362 | approved | openfda |
| Mar 5, 2024 | 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. | ORIGBLA761362 | approved | openfda |
| Mar 5, 2024 | Denosumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-05 (see label) | SUPPLBLA125320 | approved | openfda |
| Mar 1, 2024 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-01 (see label) | SUPPLBLA761210 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Feb 23, 2024 | Cisplatin | Health Canada CA | cancer not stated in this record | Marketed in Canada as CISPLATIN INJECTION BP (DIN 02536285) under ATC L01XA01 CISPLATIN. Indications are not published in the Drug Product… | DIN02536285 | approvedsource: Marketed | health-canada-dpd |
| Feb 20, 2024 | Teclistamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-20 (see label) | SUPPLBLA761291 | approved | openfda |
| Feb 16, 2024 | Pomalidomide | EMA EU | Multiple Myeloma | Pomalidomide Viatris in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma… | centralisedEMEA/H/C/006195 | approved | ema |
| Feb 16, 2024 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-16 (see label) | SUPPLNDA208065 | approved | openfda |
| Feb 16, 2024 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-16 (see label) | SUPPLNDA208065 | approved | openfda |
| Feb 15, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-15 (see label) | SUPPLBLA761139 | approved | openfda |
| Feb 15, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-15 (see label) | SUPPLBLA761139 | approved | openfda |
| Feb 15, 2024 | Tepotinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-15 (see label) | SUPPLNDA214096 | approved | openfda |
| Feb 13, 2024 | Irinotecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-02-13 (see label) | SUPPLNDA207793 | approved | openfda |
| Feb 12, 2024 | Nivolumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as OPDUALAG (DIN 02541416) under ATC L01FY02 NIVOLUMAB AND RELATLIMAB. Indications are not published in the Drug Product… | DIN02541416 | approvedsource: Marketed | health-canada-dpd |
| Feb 9, 2024 | Eribulin | EMA EU | cancer not stated in this record | Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at… | centralisedEMEA/H/C/006134 | approved | ema |
| approvedsource: Marketed |
| health-canada-dpd |
| Jan 31, 2024 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-31 (see label) | SUPPLNDA208065 | approved | openfda |
| Jan 31, 2024 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-31 (see label) | SUPPLNDA208065 | approved | openfda |
| Jan 26, 2024 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-26 (see label) | SUPPLBLA125554 | approved | openfda |
| Jan 25, 2024 | Momelotinib | EMA EU | cancer not stated in this record | Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who… | centralisedEMEA/H/C/005768 | approved | ema |
| Jan 25, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-25 (see label) | SUPPLBLA125514 | approved | openfda |
| Jan 24, 2024 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NYPOZI (DIN 02521008) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database — see… | DIN02521008 | approvedsource: Marketed | health-canada-dpd |
| Jan 24, 2024 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NYPOZI (DIN 02520990) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database — see… | DIN02520990 | approvedsource: Marketed | health-canada-dpd |
| Jan 24, 2024 | Selumetinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-24 (see label) | SUPPLNDA213756 | approved | openfda |
| Jan 23, 2024 | Elranatamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELREXFIO (DIN 02543567) under ATC L01FX32 ELRANATAMAB. Indications are not published in the Drug Product Database —… | DIN02543567 | approvedsource: Marketed | health-canada-dpd |
| Jan 23, 2024 | Elranatamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as ELREXFIO (DIN 02543559) under ATC L01FX32 ELRANATAMAB. Indications are not published in the Drug Product Database —… | DIN02543559 | approvedsource: Marketed | health-canada-dpd |
| Jan 19, 2024 | Erdafitinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-19 (see label) | SUPPLNDA212018 | approved | openfda |
| Jan 19, 2024 | Erdafitinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-19 (see label) | SUPPLNDA212018 | approved | openfda |
| Jan 18, 2024 | Alpelisib | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-18 (see label) | SUPPLNDA212526 | approved | openfda |
| Jan 12, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-01-12 (see label) | SUPPLBLA125514 | approved | openfda |
| Jan 8, 2024 | Eribulin | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-ERIBULIN (DIN 02539136) under ATC L01XX41 ERIBULIN. Indications are not published in the Drug Product Database —… | DIN02539136 | withdrawnsource: Dormantsince Jul 2, 2026 | health-canada-dpd |