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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
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days agoSource updated unknown3 authority · jurisdiction pairs ingested
Feed
Latest approval date first; records without a date are listed last. Filters combine.
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 3, 2019 | Abemaciclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VERZENIO (DIN 02487101) under ATC L01EF03 ABEMACICLIB. Indications are not published in the Drug Product Database —… | DIN02487101 | approvedsource: Marketed | health-canada-dpd |
| Jul 3, 2019 | Abemaciclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as VERZENIO (DIN 02487098) under ATC L01EF03 ABEMACICLIB. Indications are not published in the Drug Product Database —… | DIN02487098 | approvedsource: Marketed | health-canada-dpd |
| Jul 3, 2019 | Selinexor | FDA US | Multiple Myeloma | . In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at… | ORIGNDA212306 | approved | openfda |
| Jul 3, 2019 | Selinexor | FDA US | Multiple Myeloma | In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one… | ORIGNDA212306 | approved | openfda |
| Jul 1, 2019 | Hydroxycarbamide | EMA EU | cancer not stated in this record | Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 9 months of age. | centralisedEMEA/H/C/004837 | approved | ema |
| Jul 1, 2019 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2019-07-01 (see label) | SUPPLNDA208558 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2019 | Cemiplimab | EMA EU | cancer not stated in this record | Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2019 | Gilteritinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-29 (see label) | SUPPLNDA211349 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 25, 2019 | Bortezomib | FDA US | cancer not stated in this record | Efficacy supplement 2019-04-25 (see label) | SUPPLNDA021602 | 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.
| centralisedEMEA/H/C/004844 |
| approved |
| ema |
| Jun 27, 2019 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-27 (see label) | SUPPLBLA761036 | approved | openfda |
| Jun 26, 2019 | Gefitinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as SANDOZ GEFITINIB (DIN 02487748) under ATC L01EB01 GEFITINIB. Indications are not published in the Drug Product… | DIN02487748 | withdrawnsource: Cancelled Post Marketsince Jul 31, 2026 | health-canada-dpd |
| Jun 25, 2019 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as TOLAK (DIN 02485346) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database — see… | DIN02485346 | approvedsource: Marketed | health-canada-dpd |
| Jun 20, 2019 | Treosulfan | EMA EU | cancer not stated in this record | Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell… | centralisedEMEA/H/C/004751 | approved | ema |
| Jun 20, 2019 | Talazoparib | EMA EU | cancer not stated in this record | Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient… | centralisedEMEA/H/C/004674 | approved | ema |
| Jun 20, 2019 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/004556 | approved | ema |
| Jun 20, 2019 | Dexamethasone | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-20 (see label) | SUPPLNDA208742 | approved | openfda |
| Jun 17, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 10, 2019 | Polatuzumab Vedotin | FDA US | Diffuse Large B-Cell Lymphoma | in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after… | ORIGBLA761121 | approved | openfda |
| Jun 10, 2019 | Polatuzumab Vedotin | FDA US | High Grade B-Cell Lymphoma | in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have… | ORIGBLA761121 | approved | openfda |
| Jun 10, 2019 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-10 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 6, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as OGIVRI (DIN 02474433) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database — see… | DIN02474433 | approvedsource: Marketed | health-canada-dpd |
| Jun 6, 2019 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as OGIVRI (DIN 02474425) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database — see… | DIN02474425 | approvedsource: Marketed | health-canada-dpd |
| Jun 6, 2019 | Fluorouracil | Health Canada CA | cancer not stated in this record | Marketed in Canada as FLUOROURACIL INJECTION (DIN 02473771) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug… | DIN02473771 | approvedsource: Marketed | health-canada-dpd |
| Jun 3, 2019 | Abiraterone Acetate | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-03 (see label) | SUPPLNDA202379 | approved | openfda |
| Jun 3, 2019 | Abiraterone | FDA US | cancer not stated in this record | Efficacy supplement 2019-06-03 (see label) | SUPPLNDA202379 | approved | openfda |
| May 28, 2019 | Lenalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-28 (see label) | SUPPLNDA021880 | approved | openfda |
| May 24, 2019 | Cemiplimab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LIBTAYO (DIN 02487144) under ATC L01FF06 CEMIPLIMAB. Indications are not published in the Drug Product Database — see… | DIN02487144 | approvedsource: Marketed | health-canada-dpd |
| May 24, 2019 | Cemiplimab | Health Canada CA | cancer not stated in this record | Marketed in Canada as LIBTAYO (DIN 02487152) under ATC L01FF06 CEMIPLIMAB. Indications are not published in the Drug Product Database — see… | DIN02487152 | withdrawnsource: Cancelled Post Marketsince Dec 8, 2023 | health-canada-dpd |
| May 24, 2019 | Tisagenlecleucel | Health Canada CA | cancer not stated in this record | Marketed in Canada as KYMRIAH (DIN 02480514) under ATC L01XL04 TISAGENLECLEUCEL. Indications are not published in the Drug Product Database… | DIN02480514 | approvedsource: Marketed | health-canada-dpd |
| May 24, 2019 | Ruxolitinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-24 (see label) | SUPPLNDA202192 | approved | openfda |
| May 24, 2019 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-24 (see label) | SUPPLNDA210496 | approved | openfda |
| May 24, 2019 | Alpelisib | FDA US | Malignant Breast Neoplasm | PIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth… | ORIGNDA212526 | approved | openfda |
| May 20, 2019 | Fulvestrant | FDA US | Malignant Breast Neoplasm | Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal… | ORIGNDA210326 | approved | openfda |
| May 17, 2019 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TASIGNA (DIN 02481715) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see… | DIN02481715 | withdrawnsource: Cancelled Post Marketsince Oct 4, 2023 | health-canada-dpd |
| May 16, 2019 | Trastuzumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-16 (see label) | SUPPLBLA761091 | approved | openfda |
| May 15, 2019 | Venetoclax | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-15 (see label) | SUPPLNDA208573 | approved | openfda |
| May 14, 2019 | Avelumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-14 (see label) | SUPPLBLA761049 | approved | openfda |
| May 13, 2019 | Aflibercept | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-13 (see label) | SUPPLBLA125387 | approved | openfda |
| May 10, 2019 | Ramucirumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-10 (see label) | SUPPLBLA125477 | approved | openfda |
| May 8, 2019 | Erlotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-ERLOTINIB (DIN 02483939) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database… | DIN02483939 | withdrawnsource: Dormantsince Dec 1, 2021 | health-canada-dpd |
| May 8, 2019 | Erlotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-ERLOTINIB (DIN 02483920) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database… | DIN02483920 | withdrawnsource: Dormantsince Oct 1, 2021 | health-canada-dpd |
| May 8, 2019 | Erlotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as NAT-ERLOTINIB (DIN 02483912) under ATC L01EB02 ERLOTINIB. Indications are not published in the Drug Product Database… | DIN02483912 | withdrawnsource: Dormantsince May 1, 2021 | health-canada-dpd |
| May 7, 2019 | Sunitinib | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-07 (see label) | SUPPLNDA021938 | approved | openfda |
| May 6, 2019 | Lorlatinib | EMA EU | Lung Non-Small Cell Carcinoma | Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small… | centralisedEMEA/H/C/004646 | approved | ema |
| May 6, 2019 | Paclitaxel | EMA EU | cancer not stated in this record | Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for… | centralisedEMEA/H/C/004441 | approved | ema |
| May 6, 2019 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-06 (see label) | SUPPLBLA761034 | approved | openfda |
| May 6, 2019 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-06 (see label) | SUPPLBLA761034 | approved | openfda |
| May 3, 2019 | Trastuzumab Emtansine | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-03 (see label) | SUPPLBLA125427 | approved | openfda |
| May 2, 2019 | Ivosidenib | FDA US | cancer not stated in this record | Efficacy supplement 2019-05-02 (see label) | SUPPLNDA211192 | approved | openfda |
| May 1, 2019 | Dinutuximab | Health Canada CA | cancer not stated in this record | Marketed in Canada as UNITUXIN (DIN 02483076) under ATC L01FX06 DINUTUXIMAB BETA. Indications are not published in the Drug Product… | DIN02483076 | approvedsource: Marketed | health-canada-dpd |