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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Feb 28, 2023 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-28 (see label) | SUPPLNDA205054 | approved | openfda |
| Feb 27, 2023 | Mitomycin | Health Canada CA | cancer not stated in this record | Marketed in Canada as MITOMYCIN FOR INJECTION, USP (DIN 02531941) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug… | DIN02531941 | approvedsource: Marketed | health-canada-dpd |
| Feb 20, 2023 | Tremelimumab | EMA EU | cancer not stated in this record | Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular… | centralisedEMEA/H/C/006016 | approved | ema |
| Feb 20, 2023 | Tremelimumab | EMA EU | Lung Non-Small Cell Carcinoma | Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults… | centralisedEMEA/H/C/004650 | withdrawn | ema |
| Feb 15, 2023 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIOTEPA FOR INJECTION USP (DIN 02526425) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug… | DIN02526425 | approvedsource: Marketed | health-canada-dpd |
| Feb 15, 2023 | Thiotepa | Health Canada CA | cancer not stated in this record | Marketed in Canada as THIOTEPA FOR INJECTION USP (DIN 02526417) under ATC L01AC01 THIOTEPA. Indications are not published in the Drug… | DIN02526417 | approvedsource: Marketed | health-canada-dpd |
| Feb 15, 2023 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-15 (see label) | SUPPLBLA125554 | approved | openfda |
| Feb 15, 2023 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-15 (see label) | SUPPLBLA125554 | approved | openfda |
| Feb 15, 2023 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-15 (see label) | SUPPLBLA125554 | approved | openfda |
| Feb 15, 2023 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-15 (see label) | SUPPLBLA125377 | approved | openfda |
| Feb 9, 2023 | Dostarlimab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-09 (see label) | SUPPLBLA761174 | approved | openfda |
| Feb 9, 2023 | Dostarlimab | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-09 (see label) | SUPPLBLA761174 | approved | openfda |
| Feb 8, 2023 | Aflibercept | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-08 (see label) | SUPPLBLA125387 | approved | openfda |
| Feb 3, 2023 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Efficacy supplement 2023-02-03 (see label) | SUPPLBLA761115 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 30, 2023 | Abiraterone Acetate | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP ABIRATERONE (DIN 02529629) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 22, 2022 | Mosunetuzumab | FDA US | Follicular Lymphoma | LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory… |
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 |
| Jan 30, 2023 | Bendamustine | Health Canada CA | cancer not stated in this record | Marketed in Canada as BENVYON (DIN 02524309) under ATC L01AA09 BENDAMUSTINE. Indications are not published in the Drug Product Database —… | DIN02524309 | approvedsource: Marketed | health-canada-dpd |
| Jan 27, 2023 | Pirtobrutinib | FDA US | Chronic Lymphocytic Leukemia | . This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent… | ORIGNDA216059 | approved | openfda |
| Jan 27, 2023 | Pirtobrutinib | FDA US | Mantle Cell Lymphoma | Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK… | ORIGNDA216059 | approved | openfda |
| Jan 27, 2023 | Elacestrant | FDA US | Malignant Breast Neoplasm | ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth… | ORIGNDA217639 | approved | openfda |
| Jan 26, 2023 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-01-26 (see label) | SUPPLBLA125514 | approved | openfda |
| Jan 19, 2023 | Zanubrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-01-19 (see label) | SUPPLNDA213217 | approved | openfda |
| Jan 19, 2023 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2023-01-19 (see label) | SUPPLBLA761036 | approved | openfda |
| Jan 19, 2023 | Tucatinib | FDA US | cancer not stated in this record | Efficacy supplement 2023-01-19 (see label) | SUPPLNDA213411 | approved | openfda |
| Jan 17, 2023 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-SUNITINIB (DIN 02524058) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02524058 | approvedsource: Marketed | health-canada-dpd |
| Jan 10, 2023 | Enfortumab Vedotin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PADCEV (DIN 02521911) under ATC L01FX13 ENFORTUMAB VEDOTIN. Indications are not published in the Drug Product… | DIN02521911 | approvedsource: Marketed | health-canada-dpd |
| Jan 3, 2023 | Selumetinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as KOSELUGO (DIN 02530147) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database —… | DIN02530147 | approvedsource: Marketed | health-canada-dpd |
| Jan 3, 2023 | Selumetinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as KOSELUGO (DIN 02530139) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database —… | DIN02530139 | approvedsource: Marketed | health-canada-dpd |
| ORIGBLA761263 |
| approved |
| openfda |
| Dec 21, 2022 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-21 (see label) | SUPPLNDA209115 | approved | openfda |
| Dec 20, 2022 | Loncastuximab Tesirine | EMA EU | High Grade B-Cell Lymphoma | Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)… | centralisedEMEA/H/C/005685 | approved | ema |
| Dec 19, 2022 | Ruxolitinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-19 (see label) | SUPPLNDA202192 | approved | openfda |
| Dec 16, 2022 | Plerixafor | EMA EU | cancer not stated in this record | Adult patients Plerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of… | centralisedEMEA/H/C/005943 | approved | ema |
| Dec 16, 2022 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-16 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 15, 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… | ORIGNDA216078 | approved | openfda |
| Dec 15, 2022 | Bendamustine | FDA US | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | ORIGNDA216078 | approved | openfda |
| Dec 14, 2022 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA209472 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 14, 2022 | Capecitabine | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-14 (see label) | SUPPLNDA020896 | approved | openfda |
| Dec 13, 2022 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-13 (see label) | SUPPLNDA212436 | approved | openfda |
| Dec 13, 2022 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2022-12-13 (see label) | SUPPLNDA207103 | approved | openfda |
| Dec 12, 2022 | Adagrasib | FDA US | cancer not stated in this record | *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued… | ORIGNDA216340 | approved | openfda |
| Dec 12, 2022 | Adagrasib | FDA US | Malignant Colorectal Neoplasm | Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or… | ORIGNDA216340 | approved | openfda |
| Dec 12, 2022 | Adagrasib | FDA US | Lung Non-Small Cell Carcinoma | Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or… | ORIGNDA216340 | approved | openfda |
| Dec 9, 2022 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients… | centralisedEMEA/H/C/005848 | withdrawnsince May 2, 2025 | ema |