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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Dec 9, 2022 | Lutetium (177lu) Vipivotide Tetraxetan | EMA EU | cancer not stated in this record | Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for… | centralisedEMEA/H/C/005483 | approved | ema |
| Dec 9, 2022 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-09 (see label) | SUPPLNDA209191 | approved | openfda |
| Dec 9, 2022 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-09 (see label) | SUPPLBLA761034 | approved | openfda |
| Dec 7, 2022 | Bendamustine | FDA US | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a… | ORIGNDA215033 | approved | openfda |
| Dec 7, 2022 | Bendamustine | FDA US | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a… | ORIGNDA212209 | approved | openfda |
| Dec 7, 2022 | Bendamustine | FDA US | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | ORIGNDA212209 | approved | openfda |
| Dec 2, 2022 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-02 (see label) | SUPPLBLA761034 | approved | openfda |
| Dec 1, 2022 | Olutasidenib | FDA US | Acute Myeloid Leukemia | Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute… | ORIGNDA215814 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 29, 2022 | Methotrexate | FDA US | cancer not stated in this record | Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) •… | ORIGNDA212479 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 28, 2022 | Cobimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-28 (see label) | SUPPLNDA206192 | 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.
| approved |
| openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Mycosis Fungoides | Treatment of adults with mycosis fungoides | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | cancer not stated in this record | Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) •… | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Mycosis Fungoides | Treatment of adults with mycosis fungoides | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | cancer not stated in this record | Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) •… | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Mycosis Fungoides | Treatment of adults with mycosis fungoides | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | cancer not stated in this record | Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) •… | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Mycosis Fungoides | Treatment of adults with mycosis fungoides | ORIGNDA212479 | approved | openfda |
| Nov 29, 2022 | Methotrexate | FDA US | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | ORIGNDA212479 | approved | openfda |
| Nov 28, 2022 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as LAPELGA (DIN 02529343) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02529343 | approvedsource: Marketed | health-canada-dpd |
| Nov 22, 2022 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-22 (see label) | SUPPLNDA208419 | approved | openfda |
| Nov 22, 2022 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-22 (see label) | SUPPLNDA208419 | approved | openfda |
| Nov 22, 2022 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-22 (see label) | SUPPLNDA208419 | approved | openfda |
| Nov 22, 2022 | 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 | ORIGNDA215813 | approved | openfda |
| Nov 22, 2022 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA215813 | approved | openfda |
| Nov 22, 2022 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC | ORIGNDA215813 | approved | openfda |
| Nov 22, 2022 | 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… | ORIGNDA215813 | approved | openfda |
| Nov 22, 2022 | Docetaxel | FDA US | Malignant Breast Neoplasm | Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and… | ORIGNDA215813 | approved | openfda |
| Nov 22, 2022 | Alpelisib | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-22 (see label) | SUPPLNDA212526 | approved | openfda |
| Nov 14, 2022 | Mirvetuximab Soravtansine | FDA US | Malignant Peritoneal Neoplasm | ELAHERE ® is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial… | ORIGBLA761310 | approved | openfda |
| Nov 10, 2022 | Brentuximab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-10 (see label) | SUPPLBLA125388 | approved | openfda |
| Nov 10, 2022 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-10 (see label) | SUPPLBLA761069 | approved | openfda |
| Nov 9, 2022 | Sorafenib | EMA EU | cancer not stated in this record | Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell… | centralisedEMEA/H/C/005921 | approved | ema |
| Nov 8, 2022 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-08 (see label) | SUPPLBLA761097 | approved | openfda |
| Nov 7, 2022 | Lutetium (177lu) Vipivotide Tetraxetan | Health Canada CA | cancer not stated in this record | Marketed in Canada as PLUVICTO (DIN 02530198) under ATC V10XX05 LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN. Indications are not published in… | DIN02530198 | approvedsource: Marketed | health-canada-dpd |
| Nov 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-04 (see label) | SUPPLBLA761139 | approved | openfda |
| Nov 4, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-04 (see label) | SUPPLBLA761139 | approved | openfda |
| Nov 4, 2022 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2022-11-04 (see label) | SUPPLBLA761210 | approved | openfda |
| Oct 27, 2022 | Tagraxofusp | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-27 (see label) | SUPPLBLA761116 | approved | openfda |
| Oct 25, 2022 | Teclistamab | FDA US | Multiple Myeloma | TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and… | ORIGBLA761291 | approved | openfda |
| Oct 21, 2022 | Tremelimumab | FDA US | cancer not stated in this record | in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung… | ORIGBLA761289 | approved | openfda |
| Oct 21, 2022 | Tremelimumab | FDA US | Hepatocellular Carcinoma | in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). | ORIGBLA761289 | approved | openfda |
| Oct 21, 2022 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-21 (see label) | SUPPLBLA761069 | approved | openfda |
| Oct 14, 2022 | Pexidartinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-14 (see label) | SUPPLNDA211810 | approved | openfda |