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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 17 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 |
|---|---|---|---|---|---|---|---|
| Nov 22, 2024 | Mosunetuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761263 | approved | openfda |
| Nov 22, 2024 | Teclistamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761291 | approved | openfda |
| Nov 22, 2024 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-22 (see label) | SUPPLBLA761115 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | cancer not stated in this record | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. •… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR)… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with… | ORIGNDA219097 | approved | openfda |
| Nov 22, 2024 | Imatinib | FDA US | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | ORIGNDA219097 | approved | openfda |
| Nov 20, 2024 | Zanidatamab | FDA US | cancer not stated in this record | *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for… | ORIGBLA761416 | approved | openfda |
| Nov 20, 2024 | Zanidatamab | FDA US | Malignant Biliary Tract Neoplasm | Biliary Tract Cancer (BTC) • for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as… | ORIGBLA761416 | approved | openfda |
| Nov 20, 2024 | Zanidatamab | FDA US | Esophageal Adenocarcinoma | in combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive… | ORIGBLA761416 | approved | openfda |
| Nov 20, 2024 | Zanidatamab | FDA US | Esophageal Adenocarcinoma | Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr,… | ORIGBLA761416 | approved | openfda |
| Nov 19, 2024 | Lisocabtagene Maraleucel | Health Canada CA | cancer not stated in this record | Marketed in Canada as BREYANZI (DIN 02527138) under ATC L01XL08 LISOCABTAGENE MARALEUCEL. Indications are not published in the Drug Product… | DIN02527138 | approvedsource: Marketed | health-canada-dpd |
| Nov 15, 2024 | Revumenib | FDA US | Acute Myeloid Leukemia | REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene… | ORIGNDA218944 | approved | openfda |
| Nov 14, 2024 | Pomalidomide | EMA EU | Multiple Myeloma | Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma… | centralisedEMEA/H/C/006302 | approved | ema |
| Nov 14, 2024 | Mirvetuximab Soravtansine | EMA EU | Malignant Peritoneal Neoplasm | Elahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high… | centralisedEMEA/H/C/005036 | approved | ema |
| Nov 13, 2024 | Abemaciclib | FDA US | cancer not stated in this record | Efficacy supplement 2024-11-13 (see label) | SUPPLNDA208716 | approved | openfda |
| Nov 7, 2024 | Nilotinib | FDA US | cancer not stated in this record | Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. | ORIGNDA219293 | approved | openfda |
| Nov 7, 2024 | Nilotinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included… | ORIGNDA219293 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 30, 2024 | Fruquintinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as FRUZAQLA (DIN 02551462) under ATC L01EK04 FRUQUINTINIB. Indications are not published in the Drug Product Database —… | DIN02551462 |
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 30, 2024 | Fruquintinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as FRUZAQLA (DIN 02551454) under ATC L01EK04 FRUQUINTINIB. Indications are not published in the Drug Product Database —… | DIN02551454 | approvedsource: Marketed | health-canada-dpd |
| Oct 29, 2024 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-29 (see label) | SUPPLNDA215358 | approved | openfda |
| Oct 29, 2024 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-29 (see label) | SUPPLNDA215358 | approved | openfda |
| Oct 28, 2024 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ AFATINIB (DIN 02512793) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database… | DIN02512793 | approvedsource: Marketed | health-canada-dpd |
| Oct 28, 2024 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ AFATINIB (DIN 02512785) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database… | DIN02512785 | approvedsource: Marketed | health-canada-dpd |
| Oct 28, 2024 | Afatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ AFATINIB (DIN 02512777) under ATC L01EB03 AFATINIB. Indications are not published in the Drug Product Database… | DIN02512777 | approvedsource: Marketed | health-canada-dpd |
| Oct 25, 2024 | Isatuximab | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-25 (see label) | SUPPLBLA761113 | approved | openfda |
| Oct 25, 2024 | Isatuximab | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-25 (see label) | SUPPLBLA761113 | approved | openfda |
| Oct 23, 2024 | Methotrexate | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-23 (see label) | SUPPLNDA212479 | approved | openfda |
| Oct 23, 2024 | Methotrexate | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-23 (see label) | SUPPLNDA212479 | approved | openfda |
| Oct 23, 2024 | Docetaxel | FDA US | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | ORIGNDA218711 | approved | openfda |
| Oct 23, 2024 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA218711 | approved | openfda |
| Oct 23, 2024 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA218711 | approved | openfda |
| Oct 23, 2024 | Docetaxel | FDA US | Lung Non-Small Cell Carcinoma | Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with… | ORIGNDA218711 | approved | openfda |
| Oct 23, 2024 | Docetaxel | FDA US | Malignant Breast Neoplasm | Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and… | ORIGNDA218711 | approved | openfda |
| Oct 21, 2024 | Vorasidenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VORANIGO (DIN 02551233) under ATC L01XM04 VORASIDENIB. Indications are not published in the Drug Product Database —… | DIN02551233 | approvedsource: Marketed | health-canada-dpd |
| Oct 21, 2024 | Vorasidenib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VORANIGO (DIN 02551225) under ATC L01XM04 VORASIDENIB. Indications are not published in the Drug Product Database —… | DIN02551225 | approvedsource: Marketed | health-canada-dpd |
| Oct 18, 2024 | Relugolix | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-18 (see label) | SUPPLNDA214621 | approved | openfda |
| Oct 18, 2024 | Zolbetuximab | FDA US | Gastroesophageal Junction Adenocarcinoma | VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with… | ORIGBLA761365 | approved | openfda |
| Oct 16, 2024 | Calaspargase Pegol | Health Canada CA | cancer not stated in this record | Marketed in Canada as ASPARLAS (DIN 02542943) under ATC L01 ANTINEOPLASTIC AGENTS. Indications are not published in the Drug Product… | DIN02542943 | approvedsource: Marketed | health-canada-dpd |
| Oct 15, 2024 | Azacitidine | Health Canada CA | cancer not stated in this record | Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02505177) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug… | DIN02505177 | approvedsource: Marketed | health-canada-dpd |
| Oct 11, 2024 | Avelumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-11 (see label) | SUPPLBLA761049 | approved | openfda |
| Oct 10, 2024 | Inavolisib | FDA US | Malignant Breast Neoplasm | ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA… | ORIGNDA219249 | approved | openfda |
| Oct 8, 2024 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENDAMUSTINE HYDROCHLORIDE FOR INJECTION (DIN 02542005) under ATC L01AA09 BENDAMUSTINE. Indications are not published… | DIN02542005 | approvedsource: Marketed | health-canada-dpd |
| Oct 8, 2024 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528754) under ATC L01BA04 PEMETREXED. Indications are not published in the… | DIN02528754 | approvedsource: Marketed | health-canada-dpd |
| Oct 8, 2024 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02528746) under ATC L01BA04 PEMETREXED. Indications are not published in the… | DIN02528746 | approvedsource: Marketed | health-canada-dpd |
| Oct 4, 2024 | Aminolevulinic Acid | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-04 (see label) | SUPPLNDA208081 | approved | openfda |
| Oct 3, 2024 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-03 (see label) | SUPPLBLA125554 | approved | openfda |