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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 |
|---|---|---|---|---|---|---|---|
| Sep 22, 2023 | Epcoritamab | EMA EU | cancer not stated in this record | Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma… | centralisedEMEA/H/C/005985 | approved | ema |
| Sep 15, 2023 | Tislelizumab | EMA EU | cancer not stated in this record | Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then… | |||
| Sep 15, 2023 | Crisantaspase | EMA EU | Acute Lymphoblastic Leukemia | Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and… | centralisedEMEA/H/C/005917 | approved | ema |
| Sep 15, 2023 | Elacestrant | EMA EU | Malignant Breast Neoplasm | Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative,… | centralisedEMEA/H/C/005898 | approved | ema |
| Sep 15, 2023 | Decitabine | EMA EU | Acute Myeloid Leukemia | Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are… | centralisedEMEA/H/C/005823 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 21, 2023 | Talquetamab | EMA EU | Multiple Myeloma | Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 7, 2023 | Glofitamab | EMA EU | Diffuse Large B-Cell Lymphoma | Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 4, 2023 | Ivosidenib | EMA EU | cancer not stated in this record | Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 19, 2023 | Abiraterone Acetate | EMA EU | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | centralisedEMEA/H/C/005932 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 20, 2023 | Tremelimumab | EMA EU | cancer not stated in this record | Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 20, 2022 | Loncastuximab Tesirine | EMA EU | High Grade B-Cell Lymphoma | Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 9, 2022 | Sorafenib | EMA EU | cancer not stated in this record | Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 20, 2022 | Capmatinib | EMA EU | Lung Non-Small Cell Carcinoma | Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 31, 2022 | Doxorubicin | EMA EU | cancer not stated in this record | Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults: • breast cancer that has spread to other… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 29, 2022 | Relugolix | EMA EU | Malignant Prostate Neoplasm | Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. | centralised |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 28, 2022 | 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 |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| 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… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 22, 2021 | Imatinib | EMA EU | cancer not stated in this record | Imatinib Koanaa is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl)… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 26, 2021 | Tafasitamab | EMA EU | Diffuse Large B-Cell Lymphoma | Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 24, 2021 | Abiraterone Acetate | EMA EU | Castration-Resistant Prostate Carcinoma | Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive… |
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/005919 |
| approved |
| ema |
| centralisedEMEA/H/C/005864 |
| approved |
| ema |
| centralisedEMEA/H/C/005751 |
| approved |
| ema |
| Jul 4, 2023 | Futibatinib | EMA EU | Cholangiocarcinoma | Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a… | centralisedEMEA/H/C/005627 | approved | ema |
| centralisedEMEA/H/C/005936 |
| approved |
| ema |
| approved |
| ema |
| Apr 19, 2023 | Niraparib | EMA EU | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | centralisedEMEA/H/C/005932 | approved | ema |
| centralisedEMEA/H/C/006016 |
| approved |
| ema |
| Feb 20, 2023 | Tremelimumab | EMA EU | Lung Non-Small Cell Carcinoma | Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults… | centralisedEMEA/H/C/004650 | withdrawn | ema |
| centralisedEMEA/H/C/005685 |
| approved |
| ema |
| Dec 16, 2022 | Plerixafor | EMA EU | cancer not stated in this record | Adult patients Plerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of… | centralisedEMEA/H/C/005943 | approved | ema |
| Dec 9, 2022 | Pemetrexed | EMA EU | cancer not stated in this record | Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients… | centralisedEMEA/H/C/005848 | withdrawnsince May 2, 2025 | ema |
| Dec 9, 2022 | Lutetium (177lu) Vipivotide Tetraxetan | EMA EU | cancer not stated in this record | Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for… | centralisedEMEA/H/C/005483 | approved | ema |
| centralisedEMEA/H/C/005921 |
| approved |
| ema |
| centralisedEMEA/H/C/005715 |
| approved |
| ema |
| 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 |
| centralisedEMEA/H/C/005605 |
| approved |
| ema |
| 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 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 |
| centralisedEMEA/H/C/004845 |
| approved |
| ema |
| Jun 3, 2022 | Mosunetuzumab | EMA EU | Follicular Lymphoma | Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have… | centralisedEMEA/H/C/005680 | approved | ema |
| centralisedEMEA/H/C/005320 |
| approved |
| ema |
| May 25, 2022 | Ciltacabtagene Autoleucel | EMA EU | Multiple Myeloma | Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one… | centralisedEMEA/H/C/005095 | approved | ema |
| May 24, 2022 | Leuprolide | EMA EU | Malignant Prostate Neoplasm | Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and… | centralisedEMEA/H/C/005034 | approved | ema |
| approved |
| ema |
| Apr 13, 2022 | Enfortumab Vedotin | EMA EU | Malignant Bladder Neoplasm | Muscle invasive bladder cancer (MIBC) Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical… | centralisedEMEA/H/C/005392 | approved | ema |
| Apr 4, 2022 | Lisocabtagene Maraleucel | EMA EU | cancer not stated in this record | Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL),… | centralisedEMEA/H/C/004731 | approved | ema |
| Apr 1, 2022 | Tebentafusp | EMA EU | Uveal Melanoma | Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable… | centralisedEMEA/H/C/004929 | approved | ema |
| centralisedEMEA/H/C/004780 |
| approved |
| ema |
| Mar 24, 2022 | Dasatinib | EMA EU | Acute Lymphoblastic Leukemia | Dasatinib Accord is indicated for the treatment of adult patients with: • Ph+ acute lymphoblastic leukaemia (ALL) with resistance or… | centralisedEMEA/H/C/005446 | withdrawn | ema |
| Mar 24, 2022 | Dasatinib | EMA EU | cancer not stated in this record | Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+)… | centralisedEMEA/H/C/005317 | withdrawn | ema |
| centralisedEMEA/H/C/005524 |
| approved |
| ema |
| centralisedEMEA/H/C/005522 |
| approved |
| ema |
| centralisedEMEA/H/C/005454 |
| approved |
| ema |
| 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 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 |
| centralisedEMEA/H/C/005595 |
| withdrawnsince Aug 31, 2023 |
| ema |
| centralisedEMEA/H/C/005436 |
| approved |
| ema |
| Aug 20, 2021 | Abiraterone Acetate | EMA EU | Castration-Resistant Prostate Carcinoma | Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive… | centralisedEMEA/H/C/005368 | approved | ema |
| Aug 18, 2021 | Idecabtagene Vicleucel | EMA EU | Multiple Myeloma | Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior… | centralisedEMEA/H/C/004662 | approved | ema |
| centralisedEMEA/H/C/005649 |
| approved |
| ema |
| Jun 17, 2021 | Selumetinib | EMA EU | cancer not stated in this record | Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric… | centralisedEMEA/H/C/005244 | approved | ema |