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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Mar 4, 2022 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-03-04 (see label) | SUPPLBLA125554 | approved | openfda |
| Mar 2, 2022 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02486792) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN02486792 | withdrawnsource: Cancelled Post Marketsince Nov 1, 2024 | health-canada-dpd |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 28, 2022 | Pacritinib | FDA US | cancer not stated in this record | VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 31, 2022 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION SDZ (DIN 02503352) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 30, 2021 | Everolimus | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-30 (see label) | SUPPLNDA022334 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 30, 2021 | Pemigatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMAZYRE (DIN 02519941) under ATC L01EN02 PEMIGATINIB. Indications are not published in the Drug Product Database —… | DIN02519941 |
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.
| ORIGNDA208712 |
| approved |
| openfda |
| Feb 28, 2022 | Brigatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-02-28 (see label) | SUPPLNDA208772 | approved | openfda |
| Feb 25, 2022 | Filgrastim | FDA US | cancer not stated in this record | Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving… | ORIGBLA761082 | approved | openfda |
| Feb 25, 2022 | Filgrastim | FDA US | Acute Myeloid Leukemia | Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients… | ORIGBLA761082 | approved | openfda |
| Feb 24, 2022 | Azacitidine | Health Canada CA | cancer not stated in this record | Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02507668) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug… | DIN02507668 | approvedsource: Marketed | health-canada-dpd |
| Feb 22, 2022 | Dostarlimab | Health Canada CA | cancer not stated in this record | Marketed in Canada as JEMPERLI (DIN 02523434) under ATC L01FF07 DOSTARLIMAB. Indications are not published in the Drug Product Database —… | DIN02523434 | approvedsource: Marketed | health-canada-dpd |
| Feb 16, 2022 | Tepotinib | EMA EU | Lung Non-Small Cell Carcinoma | Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring… | centralisedEMEA/H/C/005524 | approved | ema |
| Feb 15, 2022 | Ponatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-02-15 (see label) | SUPPLNDA203469 | approved | openfda |
| Feb 14, 2022 | Obinutuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-02-14 (see label) | SUPPLBLA125486 | approved | openfda |
| Feb 4, 2022 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-02-04 (see label) | SUPPLBLA125514 | approved | openfda |
| Feb 3, 2022 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as AG-LETROZOLE (DIN 02374439) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database —… | DIN02374439 | withdrawnsource: Dormantsince Aug 3, 2026 | health-canada-dpd |
| withdrawnsource: Cancelled Post Marketsince Jul 31, 2026 |
| health-canada-dpd |
| Jan 31, 2022 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2022-01-31 (see label) | SUPPLNDA208558 | approved | openfda |
| Jan 28, 2022 | Trametinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-01-28 (see label) | SUPPLNDA204114 | approved | openfda |
| Jan 28, 2022 | Dabrafenib | FDA US | cancer not stated in this record | Efficacy supplement 2022-01-28 (see label) | SUPPLNDA202806 | approved | openfda |
| Jan 25, 2022 | Tebentafusp | FDA US | Uveal Melanoma | KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is… | ORIGBLA761228 | approved | openfda |
| Jan 21, 2022 | Selpercatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as RETEVMO (DIN 02516926) under ATC L01EX22 SELPERCATINIB. Indications are not published in the Drug Product Database —… | DIN02516926 | approvedsource: Marketed | health-canada-dpd |
| Jan 21, 2022 | Selpercatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as RETEVMO (DIN 02516918) under ATC L01EX22 SELPERCATINIB. Indications are not published in the Drug Product Database —… | DIN02516918 | approvedsource: Marketed | health-canada-dpd |
| Jan 14, 2022 | Hydroxychloroquine | FDA US | cancer not stated in this record | Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and… | ORIGNDA214581 | approved | openfda |
| Jan 6, 2022 | Sotorasib | EMA EU | Lung Non-Small Cell Carcinoma | Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation… | centralisedEMEA/H/C/005522 | approved | ema |
| Jan 6, 2022 | Pemigatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMAZYRE (DIN 02519933) under ATC L01EN02 PEMIGATINIB. Indications are not published in the Drug Product Database —… | DIN02519933 | approvedsource: Marketed | health-canada-dpd |
| Dec 20, 2021 | Enfortumab Vedotin | Health Canada CA | cancer not stated in this record | Marketed in Canada as PADCEV (DIN 02521903) under ATC L01FX13 ENFORTUMAB VEDOTIN. Indications are not published in the Drug Product… | DIN02521903 | approvedsource: Marketed | health-canada-dpd |
| Dec 19, 2021 | Lenvatinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-19 (see label) | SUPPLNDA206947 | approved | openfda |
| Dec 17, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 16, 2021 | Brexucabtagene Autoleucel | Health Canada CA | cancer not stated in this record | Marketed in Canada as TECARTUS (DIN 02516667) under ATC L01XL06 BREXUCABTAGENE AUTOLEUCEL. Indications are not published in the Drug… | DIN02516667 | approvedsource: Marketed | health-canada-dpd |
| Dec 14, 2021 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-14 (see label) | SUPPLNDA208246 | approved | openfda |
| Dec 14, 2021 | Tofacitinib | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-14 (see label) | SUPPLNDA203214 | approved | openfda |
| Dec 10, 2021 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-10 (see label) | SUPPLNDA209092 | approved | openfda |
| Dec 9, 2021 | Amivantamab | EMA EU | Lung Non-Small Cell Carcinoma | Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung… | centralisedEMEA/H/C/005454 | approved | ema |
| Dec 7, 2021 | Hydroxyurea | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-07 (see label) | SUPPLNDA208843 | approved | openfda |
| Dec 6, 2021 | Lurbinectedin | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZEPZELCA (DIN 02520834) under ATC L01XX69 LURBINECTEDIN. Indications are not published in the Drug Product Database —… | DIN02520834 | withdrawnsource: Dormantsince Jun 17, 2026 | health-canada-dpd |
| Dec 6, 2021 | Tafasitamab | Health Canada CA | cancer not stated in this record | Marketed in Canada as MINJUVI (DIN 02518627) under ATC L01FX12 TAFASITAMAB. Indications are not published in the Drug Product Database —… | DIN02518627 | approvedsource: Marketed | health-canada-dpd |
| Dec 3, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-03 (see label) | SUPPLBLA125514 | approved | openfda |
| Dec 2, 2021 | Rituximab | FDA US | cancer not stated in this record | Efficacy supplement 2021-12-02 (see label) | SUPPLBLA103705 | approved | openfda |
| Dec 2, 2021 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUOROURACIL INJECTION (DIN 02473763) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug… | DIN02473763 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Nov 30, 2021 | Carfilzomib | FDA US | cancer not stated in this record | Efficacy supplement 2021-11-30 (see label) | SUPPLNDA202714 | approved | openfda |
| Nov 26, 2021 | Pemigatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMAZYRE (DIN 02519968) under ATC L01EN02 PEMIGATINIB. Indications are not published in the Drug Product Database —… | DIN02519968 | approvedsource: Marketed | health-canada-dpd |
| Nov 22, 2021 | Sirolimus | FDA US | cancer not stated in this record | FYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular… | ORIGNDA213312 | approved | openfda |
| Nov 22, 2021 | Sacituzumab Govitecan | EMA EU | Triple-Negative Breast Carcinoma | Triple-Negative Breast Cancer Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable… | centralisedEMEA/H/C/005182 | approved | ema |
| Nov 22, 2021 | Zanubrutinib | EMA EU | cancer not stated in this record | Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received… | centralisedEMEA/H/C/004978 | approved | ema |
| Nov 22, 2021 | Sacituzumab Govitecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as TRODELVY (DIN 02520788) under ATC L01FX17 SACITUZUMAB GOVITECAN. Indications are not published in the Drug Product… | DIN02520788 | approvedsource: Marketed | health-canada-dpd |
| Nov 19, 2021 | Ibuprofen | FDA US | cancer not stated in this record | Efficacy supplement 2021-11-19 (see label) | SUPPLNDA022348 | approved | openfda |
| Nov 18, 2021 | Ripretinib | EMA EU | cancer not stated in this record | Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior… | centralisedEMEA/H/C/005614 | approved | ema |
| Nov 18, 2021 | Pralsetinib | EMA EU | Lung Non-Small Cell Carcinoma | Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced… | centralisedEMEA/H/C/005413 | withdrawnsince Oct 24, 2024 | ema |
| Nov 17, 2021 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2021-11-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Nov 12, 2021 | Ropeginterferon Alfa-2b | FDA US | Polycythemia Vera | The treatment of adults with polycythemia vera. | ORIGBLA761166 | approved | openfda |