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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 23 hours 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 |
|---|---|---|---|---|---|---|---|
| Oct 24, 2019 | Gilteritinib | EMA EU | Acute Myeloid Leukemia | Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with… | centralisedEMEA/H/C/004752 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 19, 2019 | Larotrectinib | EMA EU | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 2, 2019 | Azacitidine | EMA EU | cancer not stated in this record | Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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. |
| 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 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 14, 2019 | Bevacizumab | EMA EU | cancer not stated in this record | Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 14, 2019 | Apalutamide | EMA EU | Nonmetastatic Castration-Resistant Prostate Carcinoma | Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 12, 2018 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 22, 2018 | 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 27, 2018 | Gefitinib | EMA EU | Lung Non-Small Cell Carcinoma | Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non small cell lung… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 31, 2018 | Neratinib | EMA EU | Malignant Breast Neoplasm | Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 26, 2018 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 23, 2018 | Rucaparib | EMA EU | Malignant Peritoneal Neoplasm | Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 19, 2018 | Gemtuzumab Ozogamicin | EMA EU | Acute Promyelocytic Leukemia | Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 15, 2018 | Anagrelide | EMA EU | cancer not stated in this record | Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 15, 2018 | Bevacizumab | EMA EU | cancer not stated in this record | Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 16, 2017 | Niraparib | EMA EU | Malignant Peritoneal Neoplasm | Zejula is indicated: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 26, 2017 | Lutetium (177lu) Oxodotreotide | EMA EU | cancer not stated in this record | Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 24, 2017 | Tivozanib | EMA EU | Renal Cell Carcinoma | Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are… |
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/004919 |
| approved |
| ema |
| centralisedEMEA/H/C/005300 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/004837 |
| approved |
| ema |
| centralisedEMEA/H/C/004844 |
| approved |
| ema |
| 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 |
| 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 |
| centralisedEMEA/H/C/004697 |
| approved |
| ema |
| centralisedEMEA/H/C/004452 |
| approved |
| ema |
| centralisedEMEA/H/C/004916 |
| approved |
| ema |
| centralisedEMEA/H/C/004802 |
| approved |
| ema |
| Nov 22, 2018 | Brigatinib | EMA EU | cancer not stated in this record | Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small… | centralisedEMEA/H/C/004248 | approved | ema |
| Nov 22, 2018 | Mogamulizumab | EMA EU | cancer not stated in this record | Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least… | centralisedEMEA/H/C/004232 | approved | ema |
| Nov 20, 2018 | 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/004915 | approved | ema |
| Nov 20, 2018 | Paclitaxel | EMA EU | cancer not stated in this record | Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum?sensitive… | centralisedEMEA/H/C/004154 | withdrawnsince Feb 9, 2024 | ema |
| centralisedEMEA/H/C/004826 |
| withdrawnsince Sep 27, 2024 |
| ema |
| Sep 26, 2018 | Abemaciclib | EMA EU | Malignant Breast Neoplasm | Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone… | centralisedEMEA/H/C/004302 | approved | ema |
| Sep 21, 2018 | Durvalumab | EMA EU | cancer not stated in this record | Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as… | centralisedEMEA/H/C/004771 | approved | ema |
| Sep 21, 2018 | 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/004413 | withdrawnsince Feb 4, 2021 | ema |
| Sep 21, 2018 | Pegfilgrastim | EMA EU | cancer not stated in this record | Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for… | centralisedEMEA/H/C/003961 | approved | ema |
| Sep 20, 2018 | Lenalidomide | EMA EU | cancer not stated in this record | Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed… | centralisedEMEA/H/C/004857 | approved | ema |
| Sep 20, 2018 | Binimetinib | EMA EU | cancer not stated in this record | MelanomaBinimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic… | centralisedEMEA/H/C/004579 | approved | ema |
| Sep 19, 2018 | Encorafenib | EMA EU | cancer not stated in this record | MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic… | centralisedEMEA/H/C/004580 | approved | ema |
| centralisedEMEA/H/C/004030 |
| approved |
| ema |
| Aug 23, 2018 | Axicabtagene Ciloleucel | EMA EU | cancer not stated in this record | Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)… | centralisedEMEA/H/C/004480 | approved | ema |
| Aug 23, 2018 | Cytarabine | EMA EU | cancer not stated in this record | Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with… | centralisedEMEA/H/C/004282 | approved | ema |
| Aug 23, 2018 | Daunorubicin | EMA EU | cancer not stated in this record | Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with… | centralisedEMEA/H/C/004282 | approved | ema |
| Aug 23, 2018 | Tisagenlecleucel | EMA EU | cancer not stated in this record | Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute… | centralisedEMEA/H/C/004090 | approved | ema |
| centralisedEMEA/H/C/004463 |
| approved |
| ema |
| Jul 18, 2018 | Carmustine | EMA EU | cancer not stated in this record | Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic… | centralisedEMEA/H/C/004326 | approved | ema |
| centralisedEMEA/H/C/004272 |
| approved |
| ema |
| May 22, 2018 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients… | centralisedEMEA/H/C/003958 | withdrawn | ema |
| May 16, 2018 | Trastuzumab | EMA EU | cancer not stated in this record | Metastatic breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as… | centralisedEMEA/H/C/004361 | approved | ema |
| centralisedEMEA/H/C/004204 |
| approved |
| ema |
| centralisedEMEA/H/C/004585 |
| approved |
| ema |
| Feb 9, 2018 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer… | centralisedEMEA/H/C/002575 | approved | ema |
| centralisedEMEA/H/C/004728 |
| approved |
| ema |
| Jan 8, 2018 | Fulvestrant | EMA EU | Malignant Breast Neoplasm | Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal… | centralisedEMEA/H/C/004649 | approved | ema |
| centralisedEMEA/H/C/004249 |
| approved |
| ema |
| Nov 15, 2017 | Imatinib | EMA EU | cancer not stated in this record | Imatinib Teva B.V. is indicated for the treatment of: Paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive… | centralisedEMEA/H/C/004748 | withdrawnsince May 8, 2018 | ema |
| Nov 15, 2017 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast… | centralisedEMEA/H/C/004323 | approved | ema |
| Nov 10, 2017 | Padeliporfin | EMA EU | Prostate Adenocarcinoma | Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with… | centralisedEMEA/H/C/004182 | approved | ema |
| centralisedEMEA/H/C/004123 |
| approved |
| ema |
| Sep 20, 2017 | Atezolizumab | EMA EU | cancer not stated in this record | Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic… | centralisedEMEA/H/C/004143 | approved | ema |
| Sep 18, 2017 | Avelumab | EMA EU | cancer not stated in this record | Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in… | centralisedEMEA/H/C/004338 | approved | ema |
| Sep 18, 2017 | Midostaurin | EMA EU | Acute Myeloid Leukemia | Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation… | centralisedEMEA/H/C/004095 | approved | ema |
| centralisedEMEA/H/C/004131 |
| approved |
| ema |