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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 2 days 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 |
|---|---|---|---|---|---|---|---|
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not… | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. | ORIGNDA210661 | approved | openfda |
| Jun 28, 2024 | Pemetrexed | FDA US | Lung Non-Squamous Non-Small Cell Carcinoma | in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small… | ORIGNDA210661 | approved | openfda |
| Jun 26, 2024 | Epcoritamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-26 (see label) | SUPPLBLA761324 | approved | openfda |
| Jun 25, 2024 | Thiotepa | FDA US | Breast Adenocarcinoma | TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary. | ORIGNDA216984 | approved | openfda |
| Jun 21, 2024 | Adagrasib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-21 (see label) | SUPPLNDA216340 | approved | openfda |
| Jun 18, 2024 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-18 (see label) | SUPPLBLA103792 | approved | openfda |
| Jun 17, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 14, 2024 | Blinatumomab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-14 (see label) | SUPPLBLA125557 | approved | openfda |
| Jun 14, 2024 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-14 (see label) | SUPPLBLA761069 | approved | openfda |
| Jun 13, 2024 | Repotrectinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-13 (see label) | SUPPLNDA218213 | approved | openfda |
| Jun 12, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-12 (see label) | SUPPLNDA213246 | approved | openfda |
| Jun 12, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-12 (see label) | SUPPLNDA218160 | approved | openfda |
| Jun 7, 2024 | Tirbanibulin | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLNDA213189 | approved | openfda |
| Jun 7, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 7, 2024 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-06-07 (see label) | SUPPLNDA206947 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-05-29 (see label) | SUPPLNDA213246 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 2024 | Tisotumab Vedotin | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-29 (see label) | SUPPLBLA761208 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 22, 2024 | Mirvetuximab Soravtansine | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-22 (see label) | SUPPLBLA761310 | 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.
| May 16, 2024 | Tarlatamab | FDA US | Lung Small Cell Carcinoma | IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression… | ORIGBLA761344 | approved | openfda |
| Apr 24, 2024 | Alpelisib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-24 (see label) | SUPPLNDA215039 | approved | openfda |
| Apr 24, 2024 | Alpelisib | FDA US | cancer not stated in this record | VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of… | ORIGNDA218466 | approved | openfda |
| Apr 23, 2024 | Tovorafenib | FDA US | cancer not stated in this record | OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG)… | ORIGNDA218033 | approved | openfda |
| Apr 23, 2024 | Tovorafenib | FDA US | cancer not stated in this record | OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG)… | ORIGNDA217700 | approved | openfda |
| Apr 22, 2024 | Nogapendekin Alfa Inbakicept | FDA US | Non-Muscle Invasive Bladder Carcinoma | ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle… | ORIGBLA761336 | approved | openfda |
| Apr 18, 2024 | Alectinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-18 (see label) | SUPPLNDA208434 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Malignant Thyroid Gland Neoplasm | Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Thyroid Gland Medullary Carcinoma | Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as… | ORIGNDA218160 | approved | openfda |
| Apr 10, 2024 | Selpercatinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene… | ORIGNDA218160 | approved | openfda |
| Apr 5, 2024 | Cemiplimab | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761097 | approved | openfda |
| Apr 5, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761139 | approved | openfda |
| Apr 5, 2024 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-05 (see label) | SUPPLBLA761139 | approved | openfda |
| Apr 4, 2024 | Hydroxyurea | FDA US | cancer not stated in this record | XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months… | ORIGNDA216593 | approved | openfda |
| Apr 3, 2024 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-04-03 (see label) | SUPPLNDA206947 | approved | openfda |
| Mar 19, 2024 | Ponatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-19 (see label) | SUPPLNDA203469 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | cancer not stated in this record | Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Adenocarcinoma | Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Squamous Cell Carcinoma | as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy… | ORIGBLA761232 | approved | openfda |
| Mar 13, 2024 | Tislelizumab | FDA US | Esophageal Squamous Cell Carcinoma | Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or… | ORIGBLA761232 | approved | openfda |
| Mar 7, 2024 | Zanubrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-07 (see label) | SUPPLNDA213217 | approved | openfda |
| Mar 7, 2024 | Vandetanib | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-07 (see label) | SUPPLNDA022405 | approved | openfda |
| Mar 7, 2024 | Talazoparib | FDA US | Castration-Resistant Prostate Carcinoma | HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic… | ORIGNDA217439 | approved | openfda |
| Mar 7, 2024 | Talazoparib | FDA US | Malignant Breast Neoplasm | Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g… | ORIGNDA217439 | approved | openfda |
| Mar 6, 2024 | Inotuzumab Ozogamicin | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-06 (see label) | SUPPLBLA761040 | approved | openfda |
| Mar 6, 2024 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-03-06 (see label) | SUPPLBLA125554 | approved | openfda |
| Mar 5, 2024 | Denosumab | FDA US | cancer not stated in this record | of postmenopausal women with osteoporosis at high risk for fracture. • to increase bone mass in men with osteoporosis at high risk for… | ORIGBLA761362 | approved | openfda |
| Mar 5, 2024 | Denosumab | FDA US | Malignant Breast Neoplasm | to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. | ORIGBLA761362 | approved | openfda |
| Mar 5, 2024 | Denosumab | FDA US | Malignant Prostate Neoplasm | to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. | ORIGBLA761362 | approved | openfda |