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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| 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 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 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 |
|---|---|---|---|---|---|---|---|
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA213246 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 26, 2024 | Bortezomib | FDA US | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | ORIGNDA212782 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2024 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-31 (see label) | SUPPLBLA761036 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2024 | Pemetrexed | FDA US | Pleural Malignant Mesothelioma | initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are… | ORIG |
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.
| Oct 29, 2024 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2024-10-29 (see label) | SUPPLNDA215358 | 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 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 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 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 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 |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA213246 | approved | openfda |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA218160 | approved | openfda |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA218160 | approved | openfda |
| Sep 25, 2024 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-25 (see label) | SUPPLNDA208065 | approved | openfda |
| Sep 25, 2024 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-25 (see label) | SUPPLNDA208065 | approved | openfda |
| Sep 20, 2024 | Isatuximab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-20 (see label) | SUPPLBLA761113 | approved | openfda |
| Sep 19, 2024 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-19 (see label) | SUPPLBLA761210 | approved | openfda |
| Sep 17, 2024 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-17 (see label) | SUPPLNDA209092 | approved | openfda |
| Sep 17, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Sep 12, 2024 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-12 (see label) | SUPPLNDA210496 | approved | openfda |
| Sep 12, 2024 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-12 (see label) | SUPPLNDA210498 | approved | openfda |
| Aug 26, 2024 | Bortezomib | FDA US | Multiple Myeloma | treatment of adult patients with multiple myeloma | ORIGNDA212782 | approved | openfda |
| Aug 19, 2024 | Lazertinib | FDA US | Lung Non-Small Cell Carcinoma | LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic… | ORIGNDA219008 | approved | openfda |
| Aug 19, 2024 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-19 (see label) | SUPPLBLA761210 | approved | openfda |
| Aug 15, 2024 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-15 (see label) | SUPPLBLA761069 | approved | openfda |
| Aug 7, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-07 (see label) | SUPPLBLA125514 | approved | openfda |
| Aug 6, 2024 | Vorasidenib | FDA US | Grade 2 Follicular Lymphoma | VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma… | ORIGNDA218784 | approved | openfda |
| Aug 1, 2024 | Dostarlimab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-01 (see label) | SUPPLBLA761174 | approved | openfda |
| Jul 22, 2024 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-22 (see label) | SUPPLNDA209092 | approved | openfda |
| Jul 9, 2024 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-09 (see label) | SUPPLNDA215985 | approved | openfda |
| approved |
| openfda |
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Small Cell Carcinoma | Limitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. | ORIGNDA210661 | approved | openfda |