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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 22 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 |
|---|---|---|---|---|---|---|---|
| Aug 22, 2017 | Ribociclib | EMA EU | Malignant Breast Neoplasm | Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone… | centralisedEMEA/H/C/004213 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 13, 2017 | Rituximab | EMA EU | Follicular Lymphoma | Ritemvia is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 28, 2017 | Inotuzumab Ozogamicin | EMA EU | Acute Lymphoblastic Leukemia | Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 8, 2017 | Dinutuximab Beta | EMA EU | High Risk Neuroblastoma | Qarziba is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 24, 2017 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 29, 2017 | Methotrexate | EMA EU | Acute Lymphoblastic Leukemia | In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 17, 2017 | Rituximab | EMA EU | cancer not stated in this record | Truxima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 4, 2016 | Venetoclax | EMA EU | cancer not stated in this record | Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 21, 2016 | Ixazomib | EMA EU | Multiple Myeloma | Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 14, 2016 | Irinotecan | EMA EU | Pancreatic Adenocarcinoma | ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 9, 2016 | Cabozantinib | EMA EU | Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 25, 2016 | Lenvatinib | EMA EU | Renal Cell Carcinoma | Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 22, 2016 | Bortezomib | EMA EU | cancer not stated in this record | Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 20, 2016 | Daratumumab | EMA EU | cancer not stated in this record | Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 16, 2016 | Dexamethasone | EMA EU | Multiple Myeloma | Treatment of multiple myeloma. | centralisedEMEA/H/C/004071 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 15, 2016 | Necitumumab | EMA EU | Lung Non-Small Cell Carcinoma | Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 18, 2016 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 16, 2015 | Talimogene Laherparepvec | EMA EU | Melanoma | Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 26, 2015 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 18, 2015 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 28, 2015 | Docetaxel | EMA EU | cancer not stated in this record | Breast cancer Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 20, 2015 | Bortezomib | EMA EU | cancer not stated in this record | Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of… |
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/004725 |
| withdrawn |
| ema |
| Jul 13, 2017 | Rituximab | EMA EU | cancer not stated in this record | Rituzena is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of… | centralisedEMEA/H/C/004724 | withdrawnsince Apr 10, 2019 | ema |
| Jul 13, 2017 | Rituximab | EMA EU | cancer not stated in this record | Blitzima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Blitzima is indicated for the treatment of… | centralisedEMEA/H/C/004723 | approved | ema |
| centralisedEMEA/H/C/004119 |
| approved |
| ema |
| Jun 15, 2017 | Rituximab | EMA EU | cancer not stated in this record | Riximyo is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Riximyo is indicated for the treatment of… | centralisedEMEA/H/C/004729 | approved | ema |
| Jun 15, 2017 | Rituximab | EMA EU | cancer not stated in this record | Rixathon is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rixathon is indicated for the treatment of… | centralisedEMEA/H/C/003903 | approved | ema |
| centralisedEMEA/H/C/003918 |
| approved |
| ema |
| centralisedEMEA/H/C/004488 |
| withdrawn |
| ema |
| centralisedEMEA/H/C/003756 |
| approved |
| ema |
| Mar 3, 2017 | Chlormethine | EMA EU | Mycosis Fungoides | Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients. | centralisedEMEA/H/C/002826 | approved | ema |
| centralisedEMEA/H/C/004112 |
| approved |
| ema |
| Feb 16, 2017 | Alectinib | EMA EU | ALK-Positive Lung Non-Small Cell Carcinoma | Adjuvant treatment of resected non small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following… | centralisedEMEA/H/C/004164 | approved | ema |
| centralisedEMEA/H/C/004106 |
| approved |
| ema |
| centralisedEMEA/H/C/003844 |
| approved |
| ema |
| Nov 9, 2016 | Olaratumab | EMA EU | Soft Tissue Sarcoma | Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not… | centralisedEMEA/H/C/004216 | withdrawnsince Jul 22, 2019 | ema |
| Nov 9, 2016 | Palbociclib | EMA EU | Malignant Breast Neoplasm | Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally… | centralisedEMEA/H/C/003853 | approved | ema |
| centralisedEMEA/H/C/004125 |
| approved |
| ema |
| centralisedEMEA/H/C/004163 |
| approved |
| ema |
| centralisedEMEA/H/C/004224 |
| approved |
| ema |
| Aug 18, 2016 | Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) | EMA EU | cancer not stated in this record | Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with… | centralisedEMEA/H/C/002801 | withdrawn | ema |
| centralisedEMEA/H/C/004207 |
| withdrawnsince Aug 7, 2025 |
| ema |
| Jul 22, 2016 | Bortezomib | EMA EU | cancer not stated in this record | Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of… | centralisedEMEA/H/C/004076 | approved | ema |
| Jul 22, 2016 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve… | centralisedEMEA/H/C/003895 | approved | ema |
| centralisedEMEA/H/C/004077 |
| approved |
| ema |
| May 11, 2016 | Elotuzumab | EMA EU | Multiple Myeloma | Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have… | centralisedEMEA/H/C/003967 | approved | ema |
| ema |
| centralisedEMEA/H/C/003886 |
| withdrawn |
| ema |
| Feb 1, 2016 | Osimertinib | EMA EU | Lung Non-Small Cell Carcinoma | Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA… | centralisedEMEA/H/C/004124 | approved | ema |
| centralisedEMEA/H/C/004109 |
| approved |
| ema |
| Jan 18, 2016 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve… | centralisedEMEA/H/C/004072 | approved | ema |
| Jan 14, 2016 | Pegaspargase | EMA EU | Acute Lymphoblastic Leukemia | Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients… | centralisedEMEA/H/C/003789 | approved | ema |
| Jan 14, 2016 | Asparaginase | EMA EU | Acute Lymphoblastic Leukemia | Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in… | centralisedEMEA/H/C/002661 | approved | ema |
| centralisedEMEA/H/C/002771 |
| approved |
| ema |
| Dec 2, 2015 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with… | centralisedEMEA/H/C/003788 | withdrawnsince Oct 12, 2023 | ema |
| centralisedEMEA/H/C/003905 |
| approved |
| ema |
| Nov 23, 2015 | Blinatumomab | EMA EU | Acute Lymphoblastic Leukemia | Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute… | centralisedEMEA/H/C/003731 | approved | ema |
| Nov 20, 2015 | Cobimetinib | EMA EU | Melanoma | Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma… | centralisedEMEA/H/C/003960 | approved | ema |
| Nov 19, 2015 | Cinacalcet | EMA EU | cancer not stated in this record | Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.… | centralisedEMEA/H/C/004014 | approved | ema |
| Nov 19, 2015 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve… | centralisedEMEA/H/C/003970 | approved | ema |
| Nov 19, 2015 | Carfilzomib | EMA EU | Multiple Myeloma | Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated… | centralisedEMEA/H/C/003790 | approved | ema |
| centralisedEMEA/H/C/004011 |
| withdrawnsince Oct 9, 2024 |
| ema |
| Sep 14, 2015 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesothelioma Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients… | centralisedEMEA/H/C/004114 | withdrawn | ema |
| centralisedEMEA/H/C/003925 |
| withdrawnsince Oct 30, 2018 |
| ema |
| Aug 28, 2015 | Panobinostat | EMA EU | Multiple Myeloma | Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory… | centralisedEMEA/H/C/003725 | approved | ema |
| Aug 14, 2015 | Sonidegib | EMA EU | Basal Cell Carcinoma | Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative… | centralisedEMEA/H/C/002839 | approved | ema |
| Aug 14, 2015 | Dinutuximab | EMA EU | High Risk Neuroblastoma | Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received… | centralisedEMEA/H/C/002800 | withdrawnsince Mar 20, 2017 | ema |
| centralisedEMEA/H/C/003984 |
| approved |
| ema |
| Jul 20, 2015 | Nivolumab | EMA EU | Lung Non-Small Cell Carcinoma | Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior… | centralisedEMEA/H/C/003840 | withdrawnsince Nov 30, 2015 | ema |
| Jul 17, 2015 | Pembrolizumab | EMA EU | cancer not stated in this record | Melanoma Keytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced… | centralisedEMEA/H/C/003820 | approved | ema |