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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
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days 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 |
|---|---|---|---|---|---|---|---|
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470721) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470721 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470713) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470713 | approvedsource: Marketed | health-canada-dpd |
| Jan 6, 2020 | Dasatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as APO-DASATINIB (DIN 02470705) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database… | DIN02470705 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 27, 2019 | Axicabtagene Ciloleucel | Health Canada CA | cancer not stated in this record | Marketed in Canada as YESCARTA (DIN 02485648) under ATC L01XL03 AXICABTAGENE CILOLEUCEL. 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.
| Trastuzumab Deruxtecan |
| FDA US |
| Tumor-agnostic |
| HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or… |
| ORIGBLA761139 |
| approved |
| openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Lung Non-Small Cell Carcinoma | HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Tumor-agnostic | HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Lung Non-Small Cell Carcinoma | HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | as adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Trastuzumab Deruxtecan | FDA US | Malignant Breast Neoplasm | HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast… | ORIGBLA761139 | approved | openfda |
| Dec 20, 2019 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02492768) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in… | DIN02492768 | approvedsource: Marketed | health-canada-dpd |
| Dec 20, 2019 | Neratinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see… | DIN02490536 | approvedsource: Marketed | health-canada-dpd |
| Dec 19, 2019 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/005312 | approved | ema |
| Dec 18, 2019 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487500) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02487500 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2019 | Cabazitaxel | Health Canada CA | cancer not stated in this record | Marketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487497) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug… | DIN02487497 | approvedsource: Marketed | health-canada-dpd |
| Dec 18, 2019 | Enfortumab Vedotin | FDA US | cancer not stated in this record | have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing… | ORIGBLA761137 | approved | openfda |
| Dec 18, 2019 | Enfortumab Vedotin | FDA US | Malignant Bladder Neoplasm | in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after… | ORIGBLA761137 | approved | openfda |
| Dec 16, 2019 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2019-12-16 (see label) | SUPPLNDA203415 | approved | openfda |
| Dec 12, 2019 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-12-12 (see label) | SUPPLNDA208246 | approved | openfda |
| Dec 11, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as HERZUMA (DIN 02480794) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02480794 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 2019 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUXIMA (DIN 02478390) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02478390 | approvedsource: Marketed | health-canada-dpd |
| Dec 11, 2019 | Rituximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRUXIMA (DIN 02478382) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see… | DIN02478382 | approvedsource: Marketed | health-canada-dpd |
| Dec 10, 2019 | Lutetium (177lu) Oxodotreotide | Health Canada CA | cancer not stated in this record | Marketed in Canada as LUTATHERA (DIN 02484552) under ATC V10XX04 LUTETIUM (177LU) OXODOTREOTIDE. Indications are not published in the Drug… | DIN02484552 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2019 | Erdafitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BALVERSA (DIN 02493233) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database —… | DIN02493233 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2019 | Erdafitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BALVERSA (DIN 02493225) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database —… | DIN02493225 | approvedsource: Marketed | health-canada-dpd |
| Dec 9, 2019 | Erdafitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BALVERSA (DIN 02493217) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database —… | DIN02493217 | approvedsource: Marketed | health-canada-dpd |
| Dec 6, 2019 | Paclitaxel | FDA US | cancer not stated in this record | Efficacy supplement 2019-12-06 (see label) | SUPPLNDA021660 | approved | openfda |
| Dec 3, 2019 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-12-03 (see label) | SUPPLBLA761034 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 21, 2019 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-11-21 (see label) | SUPPLNDA210259 | approved | openfda |
| Nov 21, 2019 | Acalabrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-11-21 (see label) | SUPPLNDA210259 | approved | openfda |
| Nov 21, 2019 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2019-11-21 (see label) | SUPPLNDA021344 | approved | openfda |
| Nov 14, 2019 | Zanubrutinib | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA213217 | approved | openfda |
| Nov 14, 2019 | Zanubrutinib | FDA US | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | ORIGNDA213217 | approved | openfda |
| Nov 14, 2019 | Zanubrutinib | FDA US | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | ORIGNDA213217 | approved | openfda |
| Nov 14, 2019 | Zanubrutinib | FDA US | Waldenstrom Macroglobulinemia | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA213217 | approved | openfda |
| Nov 14, 2019 | Zanubrutinib | FDA US | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | ORIGNDA213217 | approved | openfda |
| Nov 14, 2019 | Arsenic Trioxide | EMA EU | Acute Promyelocytic Leukemia | Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate… | centralisedEMEA/H/C/005175 | approved | ema |
| Nov 14, 2019 | Bortezomib | EMA EU | cancer not stated in this record | Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult… | centralisedEMEA/H/C/005074 | approved | ema |
| Nov 14, 2019 | Clofarabine | EMA EU | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two… | centralisedEMEA/H/C/005039 | withdrawnsince Oct 18, 2023 | ema |