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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
177
| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 | 42 | Sep 22, 2026 |
| EMA | EU | 461 | 246 | 386 | 75 | 20 | Sep 18, 2026 |
Data updated 2 days 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 |
|---|---|---|---|---|---|---|---|
| May 19, 2020 | Bortezomib | Health Canada CA | cancer not stated in this record | Marketed in Canada as BORTEZOMIB FOR INJECTION (DIN 02493306) under ATC L01XG01 BORTEZOMIB. Indications are not published in the Drug… | DIN02493306 | approvedsource: Marketed | health-canada-dpd |
| May 19, 2020 | Doxorubicin | Health Canada CA | cancer not stated in this record | Marketed in Canada as TARO-DOXORUBICIN LIPOSOMAL (DIN 02493020) under ATC L01DB01 DOXORUBICIN. Indications are not published in the Drug… | DIN02493020 | approvedsource: Marketed | health-canada-dpd |
| May 19, 2020 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-19 (see label) | SUPPLNDA208558 | approved | openfda |
| May 18, 2020 | Atezolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-18 (see label) | SUPPLBLA761034 | approved | openfda |
| May 15, 2020 | Pegfilgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as ZIEXTENZO (DIN 02497395) under ATC L03AA13 PEGFILGRASTIM. Indications are not published in the Drug Product Database… | DIN02497395 | approvedsource: Marketed | health-canada-dpd |
| May 15, 2020 | Rucaparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-15 (see label) | SUPPLNDA209115 | approved | openfda |
| May 15, 2020 | Ripretinib | FDA US | cancer not stated in this record | QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior… | ORIGNDA213973 | approved | openfda |
| May 15, 2020 | Nivolumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-15 (see label) | SUPPLBLA125554 | approved | openfda |
| May 15, 2020 | Ipilimumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-15 (see label) | SUPPLBLA125377 | approved | openfda |
| May 14, 2020 | Pomalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-14 (see label) | SUPPLNDA204026 | approved | openfda |
| May 14, 2020 | Pomalidomide | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-14 (see label) | SUPPLNDA204026 | approved | openfda |
| May 13, 2020 | Fulvestrant | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-13 (see label) | SUPPLNDA021344 | approved | openfda |
| May 11, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485583) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485583 | approvedsource: Marketed | health-canada-dpd |
| May 11, 2020 | Filgrastim | Health Canada CA | cancer not stated in this record | Marketed in Canada as NIVESTYM (DIN 02485575) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database —… | DIN02485575 | approvedsource: Marketed | health-canada-dpd |
| May 8, 2020 | Selpercatinib | FDA US | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected… | ORIGNDA213246 | approved | openfda |
| May 8, 2020 | Selpercatinib | FDA US | Malignant Thyroid Gland Neoplasm | Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an… | ORIGNDA213246 | approved | openfda |
| May 8, 2020 | Selpercatinib | FDA US | Thyroid Gland Medullary Carcinoma | Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as… | ORIGNDA213246 | approved | openfda |
| May 8, 2020 | Selpercatinib | FDA US | Lung Non-Small Cell Carcinoma | Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene… | ORIGNDA213246 | approved | openfda |
| May 8, 2020 | Olaparib | FDA US | cancer not stated in this record | Efficacy supplement 2020-05-08 (see label) | SUPPLNDA208558 | approved | openfda |
| May 6, 2020 | Capmatinib | FDA US | Lung Non-Small Cell Carcinoma | TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation… | ORIGNDA213591 | approved | openfda |
| May 5, 2020 | Celecoxib | FDA US | cancer not stated in this record | ELYXYB is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ELYXYB is not indicated for the… | ORIGNDA212157 | approved | openfda |
| May 1, 2020 | Leuprolide | FDA US | Conventional Osteosarcoma | FENSOLVI ® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). FENSOLVI is… | ORIGNDA213150 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 |
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.
| Pembrolizumab |
| FDA US |
| cancer not stated in this record |
| Efficacy supplement 2020-04-28 (see label) |
| SUPPLBLA125514 |
| approved |
| openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 28, 2020 | Pembrolizumab | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-28 (see label) | SUPPLBLA125514 | approved | openfda |
| Apr 27, 2020 | Fulvestrant | Health Canada CA | cancer not stated in this record | Marketed in Canada as FULVESTRANT INJECTION (DIN 02468549) under ATC L02BA03 FULVESTRANT. Indications are not published in the Drug Product… | DIN02468549 | withdrawnsource: Cancelled Post Marketsince Mar 31, 2025 | health-canada-dpd |
| Apr 22, 2020 | Sacituzumab Govitecan | FDA US | cancer not stated in this record | Second Line or Later For the treatment of adult patients with unresectable locally advanced or mTNBC who have received two or more prior… | ORIGBLA761115 | approved | openfda |
| Apr 22, 2020 | Sacituzumab Govitecan | FDA US | Malignant Breast Neoplasm | Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer For the treatment of adult patients with unresectable locally… | ORIGBLA761115 | approved | openfda |
| Apr 22, 2020 | Sacituzumab Govitecan | FDA US | Triple-Negative Breast Carcinoma | In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with… | ORIGBLA761115 | approved | openfda |
| Apr 22, 2020 | Sacituzumab Govitecan | FDA US | Triple-Negative Breast Carcinoma | Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients… | ORIGBLA761115 | approved | openfda |
| Apr 21, 2020 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-21 (see label) | SUPPLNDA205552 | approved | openfda |
| Apr 21, 2020 | Ibrutinib | FDA US | cancer not stated in this record | Efficacy supplement 2020-04-21 (see label) | SUPPLNDA210563 | approved | openfda |
| Apr 17, 2020 | Tucatinib | FDA US | cancer not stated in this record | This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2)… | ORIGNDA213411 | approved | openfda |
| Apr 17, 2020 | Tucatinib | FDA US | Malignant Colorectal Neoplasm | in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal… | ORIGNDA213411 | approved | openfda |
| Apr 17, 2020 | Tucatinib | FDA US | HER2-Positive Breast Carcinoma | in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive… | ORIGNDA213411 | approved | openfda |
| Apr 17, 2020 | Pemigatinib | FDA US | cancer not stated in this record | Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement PEMAZYRE is indicated for the treatment of adults with relapsed or refractory… | ORIGNDA213736 | approved | openfda |
| Apr 17, 2020 | Pemigatinib | FDA US | Cholangiocarcinoma | Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic… | ORIGNDA213736 | approved | openfda |
| Apr 16, 2020 | Trastuzumab | Health Canada CA | cancer not stated in this record | Marketed in Canada as KANJINTI (DIN 02496690) under ATC L01FD01 TRASTUZUMAB. Indications are not published in the Drug Product Database —… | DIN02496690 | approvedsource: Marketed | health-canada-dpd |