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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 yesterdaySource 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 |
|---|---|---|---|---|---|---|---|
| May 22, 2023 | Avapritinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-05-22 (see label) | SUPPLNDA212608 | approved | openfda |
| May 19, 2023 | Epcoritamab | FDA US | cancer not stated in this record | For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including… | ORIGBLA761324 | approved | openfda |
| May 19, 2023 | Epcoritamab | FDA US | Follicular Lymphoma | This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this… | ORIGBLA761324 | approved | openfda |
| May 18, 2023 | Carmustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as CARMUSTINE FOR INJECTION USP (DIN 02531879) under ATC L01AD01 CARMUSTINE. Indications are not published in the Drug… | DIN02531879 | approvedsource: Marketed | health-canada-dpd |
| May 18, 2023 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-05-18 (see label) | SUPPLNDA205552 | approved | openfda |
| May 18, 2023 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-05-18 (see label) | SUPPLNDA210563 | approved | openfda |
| May 11, 2023 | Paclitaxel | FDA US | Pancreatic Adenocarcinoma | Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. | ORIGNDA216338 | approved | openfda |
| May 11, 2023 | Paclitaxel | FDA US | Lung Non-Small Cell Carcinoma | Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who… | ORIGNDA216338 | approved | openfda |
| May 11, 2023 | Paclitaxel | FDA US | Malignant Breast Neoplasm | Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant… | ORIGNDA216338 | approved | openfda |
| May 11, 2023 | Ibuprofen | FDA US | cancer not stated in this record | Efficacy supplement 2023-05-11 (see label) | SUPPLNDA022348 | approved | openfda |
| May 4, 2023 | Ivosidenib | EMA EU | cancer not stated in this record | Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML)… | centralisedEMEA/H/C/005936 | approved | ema |
| May 3, 2023 | Crisantaspase | Health Canada CA | cancer not stated in this record | Marketed in Canada as RYLAZE (DIN 02530406) under ATC L01XX02 ASPARAGINASE. Indications are not published in the Drug Product Database —… | DIN02530406 | approvedsource: Marketed | health-canada-dpd |
| May 1, 2023 | Acalabrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as CALQUENCE (DIN 02535696) under ATC L01EL02 ACALABRUTINIB. Indications are not published in the Drug Product Database… | DIN02535696 | approvedsource: Marketed | health-canada-dpd |
| May 1, 2023 | Bevacizumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as VEGZELMA (DIN 02534185) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database —… | DIN02534185 | approvedsource: Marketed | health-canada-dpd |
| May 1, 2023 | Hydroxyurea | Health Canada CA | cancer not stated in this record | Marketed in Canada as RIVA-HYDROXYUREA (DIN 02530260) under ATC L01XX05 HYDROXYCARBAMIDE. Indications are not published in the Drug Product… | DIN02530260 | approvedsource: Marketed | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 28, 2023 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-28 (see label) | SUPPLBLA761097 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 28, 2023 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02485257) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02485257 |
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.
| Apr 28, 2023 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-28 (see label) | SUPPLBLA761097 | approved | openfda |
| Apr 28, 2023 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-ABIRATERONE (DIN 02533251) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN02533251 | approvedsource: Marketed | health-canada-dpd |
| Apr 26, 2023 | Niraparib | FDA US | Malignant Peritoneal Neoplasm | for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial… | ORIGNDA214876 | approved | openfda |
| Apr 26, 2023 | Niraparib | FDA US | Malignant Peritoneal Neoplasm | for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a… | ORIGNDA214876 | approved | openfda |
| Apr 19, 2023 | Polatuzumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-19 (see label) | SUPPLBLA761121 | approved | openfda |
| Apr 19, 2023 | Abiraterone Acetate | EMA EU | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | centralisedEMEA/H/C/005932 | approved | ema |
| Apr 19, 2023 | Niraparib | EMA EU | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | centralisedEMEA/H/C/005932 | approved | ema |
| Apr 17, 2023 | Azacitidine | Health Canada CA | cancer not stated in this record | Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02529599) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug… | DIN02529599 | approvedsource: Marketed | health-canada-dpd |
| Apr 14, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-14 (see label) | SUPPLNDA020263 | approved | openfda |
| Apr 3, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-03 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 3, 2023 | Enfortumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2023-04-03 (see label) | SUPPLBLA761137 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Mar 28, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-03-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Mar 24, 2023 | Leniolisib | FDA US | cancer not stated in this record | JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients… | ORIGNDA217759 | approved | openfda |
| Mar 22, 2023 | Retifanlimab | FDA US | cancer not stated in this record | Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult… | ORIGBLA761334 | approved | openfda |
| Mar 22, 2023 | Retifanlimab | FDA US | Merkel Cell Carcinoma | Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). | ORIGBLA761334 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Tumor-agnostic | the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Malignant Colorectal Neoplasm | Limitations of Use : MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Thyroid Gland Anaplastic Carcinoma | the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Lung Non-Small Cell Carcinoma | the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Melanoma | the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Melanoma | MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | Melanoma | MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable… | ORIGNDA217513 | approved | openfda |
| Mar 16, 2023 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-03-16 (see label) | SUPPLNDA204114 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2023-03-16 (see label) | SUPPLNDA202806 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Tumor-agnostic | the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation… | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Malignant Colorectal Neoplasm | Limitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to… | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Thyroid Gland Anaplastic Carcinoma | the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an… | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Lung Non-Small Cell Carcinoma | the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Melanoma | the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement… | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Melanoma | TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF… | ORIGNDA217514 | approved | openfda |
| Mar 16, 2023 | Dabrafenib | FDA US | Melanoma | TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF… | ORIGNDA217514 | approved | openfda |
| Mar 3, 2023 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2023-03-03 (see label) | SUPPLNDA208716 | approved | openfda |
| Mar 3, 2023 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2023-03-03 (see label) | SUPPLNDA208716 | approved | openfda |