Loading oncology approvals…
Loading oncology approvals…
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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 23 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 23, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-23 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 23, 2023 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-23 (see label) | SUPPLNDA206947 | approved | openfda |
| Oct 20, 2023 | Teclistamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECVAYLI (DIN 02539764) under ATC L01FX24 TECLISTAMAB. Indications are not published in the Drug Product Database —… | DIN02539764 | approvedsource: Marketed | health-canada-dpd |
| Oct 20, 2023 | Teclistamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECVAYLI (DIN 02539756) under ATC L01FX24 TECLISTAMAB. Indications are not published in the Drug Product Database —… | DIN02539756 | approvedsource: Marketed | health-canada-dpd |
| Oct 20, 2023 | Entrectinib | FDA US | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene… | ORIGNDA218550 | approved | openfda |
| Oct 20, 2023 | Entrectinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | ORIGNDA218550 | approved | openfda |
| Oct 20, 2023 | Entrectinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-20 (see label) | SUPPLNDA212725 | approved | openfda |
| Oct 16, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-16 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 13, 2023 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-13 (see label) | SUPPLBLA125554 | approved | openfda |
| Oct 12, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-12 (see label) | SUPPLBLA125514 | approved | openfda |
| Oct 11, 2023 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-11 (see label) | SUPPLNDA210496 | approved | openfda |
| Oct 11, 2023 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-11 (see label) | SUPPLNDA210498 | approved | openfda |
| Oct 5, 2023 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2023-10-05 (see label) | SUPPLNDA215985 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 29, 2023 | Degarelix | EMA EU | Malignant Prostate Neoplasm | Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 31, 2023 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-08-31 (see label) | SUPPLNDA204114 | 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.
| centralisedEMEA/H/C/006048 |
| approved |
| ema |
| Sep 26, 2023 | Bosutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-26 (see label) | SUPPLNDA203341 | approved | openfda |
| Sep 26, 2023 | Bosutinib | FDA US | cancer not stated in this record | Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia… | ORIGNDA217729 | approved | openfda |
| Sep 26, 2023 | Bosutinib | FDA US | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or… | ORIGNDA217729 | approved | openfda |
| Sep 22, 2023 | Epcoritamab | EMA EU | cancer not stated in this record | Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma… | centralisedEMEA/H/C/005985 | approved | ema |
| Sep 18, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as AURO-SUNITINIB (DIN 02532190) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02532190 | approvedsource: Marketed | health-canada-dpd |
| Sep 15, 2023 | Momelotinib | FDA US | cancer not stated in this record | OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF… | ORIGNDA216873 | approved | openfda |
| Sep 15, 2023 | Tislelizumab | EMA EU | cancer not stated in this record | Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then… | centralisedEMEA/H/C/005919 | approved | ema |
| Sep 15, 2023 | Crisantaspase | EMA EU | Acute Lymphoblastic Leukemia | Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and… | centralisedEMEA/H/C/005917 | approved | ema |
| Sep 15, 2023 | Elacestrant | EMA EU | Malignant Breast Neoplasm | Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative,… | centralisedEMEA/H/C/005898 | approved | ema |
| Sep 15, 2023 | Decitabine | EMA EU | Acute Myeloid Leukemia | Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are… | centralisedEMEA/H/C/005823 | approved | ema |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA021029 | approved | openfda |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA021029 | approved | openfda |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA021029 | approved | openfda |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA022277 | approved | openfda |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA022277 | approved | openfda |
| Sep 14, 2023 | Temozolomide | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-14 (see label) | SUPPLNDA022277 | approved | openfda |
| Sep 13, 2023 | Niraparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZEJULA (DIN 02530031) under ATC L01XK02 NIRAPARIB. Indications are not published in the Drug Product Database — see… | DIN02530031 | approvedsource: Marketed | health-canada-dpd |
| Sep 12, 2023 | Cyclophosphamide | FDA US | cancer not stated in this record | malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s lymphoma, lymphocytic lymphoma (nodular or diffuse),… | ORIGNDA217150 | approved | openfda |
| Sep 12, 2023 | Cyclophosphamide | FDA US | Retinoblastoma | retinoblastoma | ORIGNDA217150 | approved | openfda |
| Sep 12, 2023 | Cyclophosphamide | FDA US | Ovarian Adenocarcinoma | adenocarcinoma of the ovary | ORIGNDA217150 | approved | openfda |
| Sep 12, 2023 | Cyclophosphamide | FDA US | Neuroblastoma | neuroblastoma (disseminated disease) | ORIGNDA217150 | approved | openfda |
| Sep 12, 2023 | Cyclophosphamide | FDA US | Mycosis Fungoides | mycosis fungoides (advanced disease) | ORIGNDA217150 | approved | openfda |
| Sep 12, 2023 | Cyclophosphamide | FDA US | Multiple Myeloma | multiple myeloma | ORIGNDA217150 | approved | openfda |
| Sep 11, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-SUNITINIB (DIN 02526220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02526220 | approvedsource: Marketed | health-canada-dpd |
| Sep 11, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-SUNITINIB (DIN 02526212) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02526212 | approvedsource: Marketed | health-canada-dpd |
| Sep 11, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TEVA-SUNITINIB (DIN 02526204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02526204 | approvedsource: Marketed | health-canada-dpd |
| Sep 7, 2023 | Crizotinib | FDA US | cancer not stated in this record | XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose… | ORIGNDA217581 | approved | openfda |
| Sep 7, 2023 | Crizotinib | FDA US | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic… | ORIGNDA217581 | approved | openfda |
| Sep 7, 2023 | Crizotinib | FDA US | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL)… | ORIGNDA217581 | approved | openfda |
| Sep 7, 2023 | Crizotinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-07 (see label) | SUPPLNDA202570 | approved | openfda |
| Sep 6, 2023 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-06 (see label) | SUPPLNDA212436 | approved | openfda |
| Sep 6, 2023 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-06 (see label) | SUPPLNDA207103 | approved | openfda |
| Sep 6, 2023 | Avelumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-09-06 (see label) | SUPPLBLA761049 | approved | openfda |
| Aug 31, 2023 | Plerixafor | Health Canada CA | cancer not stated in this record | Marketed in Canada as PLERIXAFOR INJECTION (DIN 02529815) under ATC L03AX16 PLERIXAFOR. Indications are not published in the Drug Product… | DIN02529815 | approvedsource: Marketed | health-canada-dpd |
| Aug 31, 2023 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2023-08-31 (see label) | SUPPLNDA202806 | approved | openfda |