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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
183
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 48 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 13 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 |
|---|---|---|---|---|---|---|---|
| Jun 20, 2025 | Etoposide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ETOPOSIDE INJECTION (DIN 02552671) under ATC L01CB01 ETOPOSIDE. Indications are not published in the Drug Product… | DIN02552671 | approvedsource: Marketed | health-canada-dpd |
| Jun 18, 2025 | Tafasitamab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-18 (see label) | SUPPLBLA761163 | approved | openfda |
| Jun 18, 2025 | Niraparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-18 (see label) | SUPPLNDA214876 | approved | openfda |
| Jun 12, 2025 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLNDA211651 | approved | openfda |
| Jun 12, 2025 | Talazoparib | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLNDA217439 | approved | openfda |
| Jun 12, 2025 | Mitomycin | FDA US | Non-Muscle Invasive Bladder Carcinoma | ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer… | ORIGNDA215793 | approved | openfda |
| Jun 12, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-12 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 11, 2025 | Taletrectinib | FDA US | ROS1-Positive Lung Non-Small Cell Carcinoma | IBTROZI ® (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small… | ORIGNDA219713 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Waldenstrom Macroglobulinemia | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Waldenstrom Macroglobulinemia | This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be… | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Zanubrutinib | FDA US | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | ORIGNDA218785 | approved | openfda |
| Jun 10, 2025 | Methotrexate | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP METHOTREXATE TABLETS (DIN 02553740) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug… | DIN02553740 | approvedsource: Marketed | health-canada-dpd |
| Jun 6, 2025 | Zolbetuximab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-06 (see label) | SUPPLBLA761365 | approved | openfda |
| Jun 6, 2025 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02546744) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02546744 | approvedsource: Marketed | health-canada-dpd |
| Jun 6, 2025 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02546736) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02546736 | approvedsource: Marketed | health-canada-dpd |
| Jun 6, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-06 (see label) | SUPPLBLA125514 | approved | openfda |
| Jun 5, 2025 | Meloxicam | FDA US | cancer not stated in this record | XIFYRM is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.… | ORIGNDA218395 | approved | openfda |
| Jun 3, 2025 | Darolutamide | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-03 (see label) | SUPPLNDA212099 | approved | openfda |
| Jun 3, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-06-03 (see label) | SUPPLBLA125514 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 27, 2025 | Arsenic Trioxide | Health Canada CA | cancer not stated in this record | Marketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02554364) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in… | DIN |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 28, 2025 | Lazertinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LAZCLUZE (DIN 02555972) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database —… | DIN02555972 |
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.
| approvedsource: Marketed |
| health-canada-dpd |
| 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… | 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 |
| May 23, 2025 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-23 (see label) | SUPPLBLA125554 | approved | openfda |
| May 23, 2025 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-23 (see label) | SUPPLBLA125377 | approved | openfda |
| May 22, 2025 | Denosumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-22 (see label) | SUPPLBLA125320 | approved | openfda |
| May 22, 2025 | Roflumilast | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-22 (see label) | SUPPLNDA217242 | approved | openfda |
| May 22, 2025 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-22 (see label) | SUPPLBLA125514 | approved | openfda |
| May 22, 2025 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-22 (see label) | SUPPLNDA020263 | approved | openfda |
| May 22, 2025 | Carfilzomib | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-22 (see label) | SUPPLNDA202714 | approved | openfda |
| May 21, 2025 | Zanubrutinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BRUKINSA (DIN 02554267) under ATC L01EL03 ZANUBRUTINIB. Indications are not published in the Drug Product Database —… | DIN02554267 | approvedsource: Marketed | health-canada-dpd |
| May 16, 2025 | Talazoparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TALZENNA (DIN 02555050) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database —… | DIN02555050 | approvedsource: Marketed | health-canada-dpd |
| May 16, 2025 | Talazoparib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TALZENNA (DIN 02492032) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database —… | DIN02492032 | approvedsource: Marketed | health-canada-dpd |
| May 15, 2025 | Retifanlimab | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-15 (see label) | SUPPLBLA761334 | approved | openfda |
| May 14, 2025 | Trastuzumab Emtansine | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-14 (see label) | SUPPLBLA125427 | approved | openfda |
| May 14, 2025 | Belzutifan | FDA US | cancer not stated in this record | Efficacy supplement 2025-05-14 (see label) | SUPPLNDA215383 | approved | openfda |
| approvedsource: Marketed |
| health-canada-dpd |
| Apr 28, 2025 | Lazertinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as LAZCLUZE (DIN 02555964) under ATC L01EB09 LAZERTINIB. Indications are not published in the Drug Product Database —… | DIN02555964 | approvedsource: Marketed | health-canada-dpd |
| 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… | centralisedEMEA/H/C/006433 | approved | ema |
| Apr 25, 2025 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as M-LETROZOLE (DIN 02549972) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product Database —… | DIN02549972 | approvedsource: Marketed | health-canada-dpd |
| Apr 24, 2025 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-NILOTINIB (DIN 02556642) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product… | DIN02556642 | approvedsource: Marketed | health-canada-dpd |
| Apr 24, 2025 | Nilotinib | Health Canada CA | cancer not stated in this record | Marketed in Canada as REDDY-NILOTINIB (DIN 02556634) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product… | DIN02556634 | approvedsource: Marketed | health-canada-dpd |
| 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 23, 2025 | Palbociclib | FDA US | cancer not stated in this record | Efficacy supplement 2025-04-23 (see label) | SUPPLNDA212436 | approved | openfda |