Loading oncology approvals…
Loading oncology approvals…
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
4,340
Distinct drugs
372
Records naming a cancer
982
Dated in the last 12 months
182
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 49 | Sep 22, 2026 |
| EMA | EU | 459 | 245 | 385 | 74 | 18 | Jul 20, 2026 |
Data updated 18 hours 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 20, 2026 | Camizestrant | EMA EU | cancer not stated in this record | Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment… | centralisedEMEA/H/C/006494 | approved | ema |
| Jul 15, 2026 | Alpelisib | EMA EU | cancer not stated in this record | Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related… | centralisedEMEA/H/C/006539 | approved | ema |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 19, 2026 | Palbociclib | EMA EU | Malignant Breast Neoplasm | Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 29, 2026 | Lurbinectedin | EMA EU | Lung Small Cell Carcinoma | Zepzelca, in combination with atezolizumab, is indicated for the maintenance treatment of adult patients with extensive-stage small cell… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 23, 2026 | Pertuzumab | EMA EU | Early Stage Breast Carcinoma | Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 16, 2026 | Nogapendekin Alfa Inbakicept | EMA EU | Non-Muscle Invasive Bladder Carcinoma | Anktiva in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 9, 2026 | Imlunestrant | EMA EU | Malignant Breast Neoplasm | Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra significantly… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 22, 2025 | Nintedanib | EMA EU | cancer not stated in this record | Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 23, 2025 | Belantamab Mafodotin | EMA EU | Multiple Myeloma | Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 30, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Evfraxy significantly… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 25, 2025 | Trabectedin | EMA EU | cancer not stated in this record | Trabectedin Accord is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 28, 2025 | 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 14, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… |
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/006624 |
| approved |
| ema |
| centralisedEMEA/H/C/006673 |
| approved |
| ema |
| May 29, 2026 | Tarlatamab | EMA EU | Lung Small Cell Carcinoma | Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who… | centralisedEMEA/H/C/006451 | approved | ema |
| May 28, 2026 | Nadofaragene Firadenovec | EMA EU | Non-Muscle Invasive Bladder Carcinoma | Adstiladrin is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle… | centralisedEMEA/H/C/005856 | approved | ema |
| centralisedEMEA/H/C/006583 |
| approved |
| ema |
| Apr 20, 2026 | Tovorafenib | EMA EU | cancer not stated in this record | Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG)… | centralisedEMEA/H/C/006140 | approved | ema |
| centralisedEMEA/H/C/006622 |
| approved |
| ema |
| Feb 12, 2026 | Aumolertinib | EMA EU | Lung Non-Small Cell Carcinoma | Aumseqa as monotherapy is indicated for:- the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC)whose… | centralisedEMEA/H/C/006069 | approved | ema |
| centralisedEMEA/H/C/006184 |
| approved |
| ema |
| Jan 8, 2026 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… | centralisedEMEA/H/C/006492 | approved | ema |
| centralisedEMEA/H/C/006734 |
| approved |
| ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006722 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006552 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Kefdensis… | centralisedEMEA/H/C/006490 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006239 | approved | ema |
| Nov 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Ponlimsi significantly… | centralisedEMEA/H/C/006238 | approved | ema |
| centralisedEMEA/H/C/006435 |
| approved |
| ema |
| Sep 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Inpostmenopausal women, denosumab… | centralisedEMEA/H/C/006434 | approved | ema |
| Sep 17, 2025 | Vimseltinib | EMA EU | cancer not stated in this record | Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically… | centralisedEMEA/H/C/006363 | approved | ema |
| Sep 17, 2025 | Vorasidenib | EMA EU | Grade 2 Follicular Lymphoma | Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an… | centralisedEMEA/H/C/006284 | approved | ema |
| centralisedEMEA/H/C/006486 |
| approved |
| ema |
| Aug 18, 2025 | 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/006739 | approved | ema |
| Aug 14, 2025 | Nirogacestat | EMA EU | cancer not stated in this record | Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment. | centralisedEMEA/H/C/006071 | approved | ema |
| centralisedEMEA/H/C/006511 |
| approved |
| ema |
| Jul 18, 2025 | Inavolisib | EMA EU | Malignant Breast Neoplasm | Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen… | centralisedEMEA/H/C/006353 | approved | ema |
| Jul 18, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… | centralisedEMEA/H/C/006268 | approved | ema |
| Jul 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab… | centralisedEMEA/H/C/006507 | approved | ema |
| Jul 17, 2025 | Mirdametinib | EMA EU | cancer not stated in this record | Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult… | centralisedEMEA/H/C/006460 | approved | ema |
| Jul 17, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006269 | approved | ema |
| Jul 17, 2025 | Obecabtagene Autoleucel | EMA EU | B Acute Lymphoblastic Leukemia | Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor… | centralisedEMEA/H/C/005907 | approved | ema |
| centralisedEMEA/H/C/006526 |
| approved |
| ema |
| Jun 30, 2025 | Trastuzumab | EMA EU | cancer not stated in this record | Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast… | centralisedEMEA/H/C/006219 | approved | ema |
| Jun 27, 2025 | Zanidatamab | EMA EU | Malignant Biliary Tract Neoplasm | Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+)… | centralisedEMEA/H/C/006380 | approved | ema |
| Jun 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab… | centralisedEMEA/H/C/006377 | approved | ema |
| Jun 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006376 | approved | ema |
| Jun 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006199 | approved | ema |
| Jun 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab… | centralisedEMEA/H/C/006152 | approved | ema |
| Jun 25, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006534 | approved | ema |
| Jun 23, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006437 | approved | ema |
| Jun 23, 2025 | Denosumab | EMA EU | cancer not stated in this record | Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Junod significantly… | centralisedEMEA/H/C/006436 | approved | ema |
| centralisedEMEA/H/C/006399 |
| approved |
| ema |
| May 26, 2025 | Denosumab | EMA EU | cancer not stated in this record | Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with… | centralisedEMEA/H/C/006398 | approved | ema |
| centralisedEMEA/H/C/006433 |
| approved |
| ema |
| Apr 23, 2025 | Linvoseltamab | EMA EU | Multiple Myeloma | Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies,… | centralisedEMEA/H/C/006370 | approved | ema |
| Apr 4, 2025 | Datopotamab Deruxtecan | EMA EU | Malignant Breast Neoplasm | Breast cancerDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor… | centralisedEMEA/H/C/006547 | approved | ema |
| centralisedEMEA/H/C/006407 |
| approved |
| ema |
| Mar 28, 2025 | Tisotumab Vedotin | EMA EU | Malignant Cervical Neoplasm | Tivdak as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease… | centralisedEMEA/H/C/005363 | approved | ema |
| centralisedEMEA/H/C/006157 |
| approved |
| ema |