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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Oct 12, 2022 | Asciminib | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-12 (see label) | SUPPLNDA215358 | approved | openfda |
| Oct 6, 2022 | Pexidartinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-06 (see label) | SUPPLNDA211810 | approved | openfda |
| Oct 3, 2022 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2022-10-03 (see label) | SUPPLNDA209092 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 2022 | Futibatinib | FDA US | Intrahepatic Cholangiocarcinoma | LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 31, 2022 | Pazopanib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-PAZOPANIB (DIN 02525666) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database… | DIN02525666 |
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.
| ORIGNDA214801 |
| approved |
| openfda |
| Sep 22, 2022 | Axitinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-22 (see label) | SUPPLNDA202324 | approved | openfda |
| Sep 21, 2022 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-21 (see label) | SUPPLNDA213246 | approved | openfda |
| Sep 21, 2022 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-21 (see label) | SUPPLNDA213246 | approved | openfda |
| Sep 20, 2022 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-SUNITINIB (DIN 02524082) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02524082 | approvedsource: Marketed | health-canada-dpd |
| Sep 20, 2022 | Sunitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-SUNITINIB (DIN 02524066) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database… | DIN02524066 | approvedsource: Marketed | health-canada-dpd |
| Sep 19, 2022 | Thalidomide | EMA EU | Multiple Myeloma | Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple… | centralisedEMEA/H/C/005715 | approved | ema |
| Sep 16, 2022 | Capmatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TABRECTA (DIN 02527405) under ATC L01EP01 CAPMATINIB. Indications are not published in the Drug Product Database —… | DIN02527405 | approvedsource: Marketed | health-canada-dpd |
| Sep 16, 2022 | Capmatinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TABRECTA (DIN 02527391) under ATC L01EP01 CAPMATINIB. Indications are not published in the Drug Product Database —… | DIN02527391 | approvedsource: Marketed | health-canada-dpd |
| Sep 15, 2022 | Nivolumab | EMA EU | Melanoma | Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of… | centralisedEMEA/H/C/005481 | approved | ema |
| Sep 15, 2022 | Doxorubicin | EMA EU | cancer not stated in this record | Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an… | centralisedEMEA/H/C/005330 | withdrawnsince Sep 22, 2025 | ema |
| Sep 15, 2022 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517647) under ATC L01BA04 PEMETREXED. Indications are not published in the… | DIN02517647 | approvedsource: Marketed | health-canada-dpd |
| Sep 15, 2022 | Pemetrexed | Health Canada CA | cancer not stated in this record | Marketed in Canada as PEMETREXED DISODIUM FOR INJECTION (DIN 02517639) under ATC L01BA04 PEMETREXED. Indications are not published in the… | DIN02517639 | approvedsource: Marketed | health-canada-dpd |
| Sep 14, 2022 | Chlormethine | Health Canada CA | cancer not stated in this record | Marketed in Canada as LEDAGA (DIN 02516764) under ATC L01AA05 CHLORMETHINE. Indications are not published in the Drug Product Database —… | DIN02516764 | approvedsource: Marketed | health-canada-dpd |
| Sep 13, 2022 | Eribulin | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-13 (see label) | SUPPLNDA201532 | approved | openfda |
| Sep 9, 2022 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-09 (see label) | SUPPLNDA213674 | approved | openfda |
| Sep 9, 2022 | Enzalutamide | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-09 (see label) | SUPPLNDA203415 | approved | openfda |
| Sep 2, 2022 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2022-09-02 (see label) | SUPPLBLA761069 | approved | openfda |
| Sep 1, 2022 | Belzutifan | Health Canada CA | cancer not stated in this record | Marketed in Canada as WELIREG (DIN 02528908) under ATC L01XX74 BELZUTIFAN. Indications are not published in the Drug Product Database — see… | DIN02528908 | approvedsource: Marketed | health-canada-dpd |
| Sep 1, 2022 | Asciminib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SCEMBLIX (DIN 02528339) under ATC L01EA06 ASCIMINIB. Indications are not published in the Drug Product Database — see… | DIN02528339 | approvedsource: Marketed | health-canada-dpd |
| Sep 1, 2022 | Asciminib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SCEMBLIX (DIN 02528320) under ATC L01EA06 ASCIMINIB. Indications are not published in the Drug Product Database — see… | DIN02528320 | approvedsource: Marketed | health-canada-dpd |
| approvedsource: Marketed |
| health-canada-dpd |
| Aug 31, 2022 | Pemetrexed | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-31 (see label) | SUPPLNDA021462 | approved | openfda |
| Aug 29, 2022 | Tretinoin | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TRETINOIN (DIN 02520036) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database… | DIN02520036 | approvedsource: Marketed | health-canada-dpd |
| Aug 26, 2022 | Pemigatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-26 (see label) | SUPPLNDA213736 | approved | openfda |
| Aug 26, 2022 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-26 (see label) | SUPPLNDA208558 | approved | openfda |
| Aug 25, 2022 | Asciminib | EMA EU | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase… | centralisedEMEA/H/C/005605 | approved | ema |
| Aug 25, 2022 | Fludarabine | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUDARABINE PHOSPHATE INJECTION, USP (DIN 02438577) under ATC L01BB05 FLUDARABINE. Indications are not published in… | DIN02438577 | approvedsource: Marketed | health-canada-dpd |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA205552 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA205552 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA205552 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA210563 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA210563 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-24 (see label) | SUPPLNDA210563 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | cancer not stated in this record | Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) • . Adult patients with chronic lymphocytic… | ORIGNDA217003 | approved | openfda |
| Aug 24, 2022 | Ibrutinib | FDA US | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | ORIGNDA217003 | approved | openfda |
| Aug 23, 2022 | Teclistamab | EMA EU | Multiple Myeloma | Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who… | centralisedEMEA/H/C/005865 | approved | ema |
| Aug 23, 2022 | Tebentafusp | Health Canada CA | cancer not stated in this record | Marketed in Canada as KIMMTRAK (DIN 02527588) under ATC L01XX75 TEBENTAFUSP. Indications are not published in the Drug Product Database —… | DIN02527588 | approvedsource: Marketed | health-canada-dpd |
| Aug 17, 2022 | Melphalan Flufenamide | EMA EU | Multiple Myeloma | Pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at… | centralisedEMEA/H/C/005681 | approved | ema |
| Aug 17, 2022 | Bevacizumab | EMA EU | cancer not stated in this record | VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… | centralisedEMEA/H/C/005534 | approved | ema |
| Aug 11, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-11 (see label) | SUPPLBLA761139 | approved | openfda |
| Aug 11, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-11 (see label) | SUPPLBLA761139 | approved | openfda |
| Aug 10, 2022 | Capmatinib | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-10 (see label) | SUPPLNDA213591 | approved | openfda |
| Aug 5, 2022 | Darolutamide | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-05 (see label) | SUPPLNDA212099 | approved | openfda |
| Aug 5, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-05 (see label) | SUPPLBLA761139 | approved | openfda |
| Aug 5, 2022 | Trastuzumab Deruxtecan | FDA US | cancer not stated in this record | Efficacy supplement 2022-08-05 (see label) | SUPPLBLA761139 | approved | openfda |
| Aug 5, 2022 | Temozolomide | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516802) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product… | DIN02516802 | approvedsource: Marketed | health-canada-dpd |