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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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 18 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 27, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-PALBOCICLIB (DIN 02552140) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02552140 | approvedsource: Marketed | health-canada-dpd |
| Sep 27, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-PALBOCICLIB (DIN 02552132) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02552132 | approvedsource: Marketed | health-canada-dpd |
| Sep 27, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as PMS-PALBOCICLIB (DIN 02552124) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02552124 | approvedsource: Marketed | health-canada-dpd |
| Sep 27, 2024 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02547694) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02547694 | approvedsource: Marketed | health-canada-dpd |
| Sep 27, 2024 | Cyclophosphamide | Health Canada CA | cancer not stated in this record | Marketed in Canada as CYCLOPHOSPHAMIDE FOR INJECTION USP (DIN 02547686) under ATC L01AA01 CYCLOPHOSPHAMIDE. Indications are not published… | DIN02547686 | approvedsource: Marketed | health-canada-dpd |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA213246 | approved | openfda |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA213246 | approved | openfda |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA218160 | approved | openfda |
| Sep 27, 2024 | Selpercatinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-27 (see label) | SUPPLNDA218160 | approved | openfda |
| Sep 25, 2024 | Osimertinib Mesylate | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-25 (see label) | SUPPLNDA208065 | approved | openfda |
| Sep 25, 2024 | Osimertinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-25 (see label) | SUPPLNDA208065 | approved | openfda |
| Sep 20, 2024 | Isatuximab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-20 (see label) | SUPPLBLA761113 | approved | openfda |
| Sep 19, 2024 | Trastuzumab | EMA EU | cancer not stated in this record | Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: as monotherapy for the treatment of those… | centralisedEMEA/H/C/006252 | approved | ema |
| Sep 19, 2024 | Rituximab | EMA EU | cancer not stated in this record | Treatment of Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis | centralisedEMEA/H/C/006224 | approved | ema |
| Sep 19, 2024 | Axitinib | EMA EU | Renal Cell Carcinoma | Axitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment… | centralisedEMEA/H/C/006206 | approved | ema |
| Sep 19, 2024 | Toripalimab | EMA EU | cancer not stated in this record | Loqtorzi, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not… | centralisedEMEA/H/C/006120 | approved | ema |
| Sep 19, 2024 | Zolbetuximab | EMA EU | cancer not stated in this record | Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first line treatment of adult… | centralisedEMEA/H/C/005868 | approved | ema |
| Sep 19, 2024 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-19 (see label) | SUPPLBLA761210 | approved | openfda |
| Sep 17, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-PALBOCICLIB (DIN 02547651) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02547651 | approvedsource: Marketed | health-canada-dpd |
| Sep 17, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-PALBOCICLIB (DIN 02547643) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02547643 | approvedsource: Marketed | health-canada-dpd |
| Sep 17, 2024 | Palbociclib | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-PALBOCICLIB (DIN 02547635) under ATC L01EF01 PALBOCICLIB. Indications are not published in the Drug Product… | DIN02547635 | approvedsource: Marketed | health-canada-dpd |
| Sep 17, 2024 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-17 (see label) | SUPPLNDA209092 | approved | openfda |
| Sep 17, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-17 (see label) | SUPPLBLA125514 | approved | openfda |
| Sep 12, 2024 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTABLE (DIN 02530635) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug… | DIN02530635 | approvedsource: Marketed | health-canada-dpd |
| Sep 12, 2024 | Encorafenib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-12 (see label) | SUPPLNDA210496 | approved | openfda |
| Sep 12, 2024 | Binimetinib | FDA US | cancer not stated in this record | Efficacy supplement 2024-09-12 (see label) | SUPPLNDA210498 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Aug 26, 2024 | Bortezomib | FDA US | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | ORIGNDA212782 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 31, 2024 | Daratumumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-31 (see label) | SUPPLBLA761036 | approved | openfda |
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.
| Aug 26, 2024 | Bortezomib | FDA US | Multiple Myeloma | treatment of adult patients with multiple myeloma | ORIGNDA212782 | approved | openfda |
| Aug 22, 2024 | Nilotinib | EMA EU | Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive | Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive… | centralisedEMEA/H/C/006315 | approved | ema |
| Aug 22, 2024 | Enzalutamide | EMA EU | Castration-Resistant Prostate Carcinoma | Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with… | centralisedEMEA/H/C/006299 | approved | ema |
| Aug 22, 2024 | Odronextamab | EMA EU | cancer not stated in this record | Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two… | centralisedEMEA/H/C/006215 | approved | ema |
| Aug 22, 2024 | Erdafitinib | EMA EU | Urothelial Carcinoma | Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC),… | centralisedEMEA/H/C/006050 | approved | ema |
| Aug 20, 2024 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as AG-LETROZOLE TABLETS (DIN 02543419) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product… | DIN02543419 | approvedsource: Marketed | health-canada-dpd |
| Aug 20, 2024 | Letrozole | Health Canada CA | cancer not stated in this record | Marketed in Canada as JAMP LETROZOLE TABLETS (DIN 02541912) under ATC L02BG04 LETROZOLE. Indications are not published in the Drug Product… | DIN02541912 | approvedsource: Marketed | health-canada-dpd |
| Aug 19, 2024 | Lazertinib | FDA US | Lung Non-Small Cell Carcinoma | LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic… | ORIGNDA219008 | approved | openfda |
| Aug 19, 2024 | Amivantamab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-19 (see label) | SUPPLBLA761210 | approved | openfda |
| Aug 15, 2024 | Durvalumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-15 (see label) | SUPPLBLA761069 | approved | openfda |
| Aug 12, 2024 | Irinotecan | Health Canada CA | cancer not stated in this record | Marketed in Canada as IRINOTECAN HYDROCHLORIDE INJECTION (DIN 02528800) under ATC L01CE02 IRINOTECAN. Indications are not published in the… | DIN02528800 | approvedsource: Marketed | health-canada-dpd |
| Aug 7, 2024 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-07 (see label) | SUPPLBLA125514 | approved | openfda |
| Aug 6, 2024 | Vorasidenib | FDA US | Grade 2 Follicular Lymphoma | VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma… | ORIGNDA218784 | approved | openfda |
| Aug 1, 2024 | Dostarlimab | FDA US | cancer not stated in this record | Efficacy supplement 2024-08-01 (see label) | SUPPLBLA761174 | approved | openfda |
| Jul 26, 2024 | Pomalidomide | EMA EU | Multiple Myeloma | Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma… | centralisedEMEA/H/C/006273 | approved | ema |
| Jul 26, 2024 | Dasatinib | EMA EU | cancer not stated in this record | Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+)… | centralisedEMEA/H/C/006251 | approved | ema |
| Jul 26, 2024 | Bevacizumab | EMA EU | cancer not stated in this record | Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian,… | centralisedEMEA/H/C/005574 | approved | ema |
| Jul 24, 2024 | Pomalidomide | EMA EU | Multiple Myeloma | Pomalidomide Krka in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma… | centralisedEMEA/H/C/006314 | approved | ema |
| Jul 24, 2024 | Pomalidomide | EMA EU | Multiple Myeloma | Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide… | centralisedEMEA/H/C/006294 | approved | ema |
| Jul 24, 2024 | Sugemalimab | EMA EU | Lung Non-Small Cell Carcinoma | Cejemly in combination with platinum-based chemotherapy is indicated for the first line treatment of adults with metastatic non small cell… | centralisedEMEA/H/C/006088 | approved | ema |
| Jul 24, 2024 | Paclitaxel | EMA EU | cancer not stated in this record | Apexelsin monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for… | centralisedEMEA/H/C/005997 | approved | ema |
| Jul 22, 2024 | Ribociclib | FDA US | cancer not stated in this record | Efficacy supplement 2024-07-22 (see label) | SUPPLNDA209092 | approved | openfda |