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
4,342
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| Authority | Jurisdiction | Records | Drugs | In force | Withdrawn / cancelled | Last 12 months | Latest dated record |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 16 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 |
|---|---|---|---|---|---|---|---|
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Breast Neoplasm | treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Breast Neoplasm | Breast Cancer treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Colorectal Neoplasm | treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy… | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Rectal Neoplasm | perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. | ORIGNDA020896 | approved | openfda |
| Apr 30, 1998 | Capecitabine | FDA US | Malignant Colon Neoplasm | Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination… | ORIGNDA020896 | approved | openfda |
| Apr 9, 1998 | Goserelin | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-09 (see label) | SUPPLNDA019726 | approved | openfda |
| Apr 9, 1998 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-09 (see label) | SUPPLNDA020011 | approved | openfda |
| Apr 2, 1998 | Filgrastim | FDA US | cancer not stated in this record | Efficacy supplement 1998-04-02 (see label) | SUPPLBLA103353 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 25, 1998 | Hydroxyurea | FDA US | cancer not stated in this record | Efficacy supplement 1998-02-25 (see label) | SUPPLNDA016295 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 30, 1998 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, headaches and toothaches | ORIGNDA020812 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 12, 1997 | Bicalutamide | FDA US | cancer not stated in this record | Efficacy supplement 1997-12-12 (see label) | SUPPLNDA020498 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Nov 26, 1997 | Rituximab | FDA US | cancer not stated in this record | . Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 10, 1997 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1997-10-10 (see label) | SUPPLNDA019839 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 30, 1997 | Irbesartan | FDA US | cancer not stated in this record | Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. | ORIGNDA020726 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 30, 1997 | Leuprolide | FDA US | cancer not stated in this record | Efficacy supplement 1997-05-30 (see label) | SUPPLNDA020517 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Mar 14, 1997 | Anagrelide | FDA US | Myeloproliferative Neoplasm | AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Feb 17, 1997 | Idarubicin | FDA US | Acute Myeloid Leukemia | IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jan 14, 1997 | Tretinoin | FDA US | cancer not stated in this record | Tretinoin Cream, USP is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the… | ORIGNDA020404 |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Dec 20, 1996 | Glatiramer | FDA US | cancer not stated in this record | COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Oct 25, 1996 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1996-10-25 (see label) | SUPPLNDA019839 | approved | openfda |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Sep 23, 1996 | Carmustine | FDA US | cancer not stated in this record | GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation,… |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| Jun 27, 1996 | Ibuprofen | FDA US | cancer not stated in this record | USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020589 | approved |
| Date | Drug | Authority · jurisdiction | Cancer | Indication (as published) | Type | Status | Source |
|---|---|---|---|---|---|---|---|
| May 28, 1996 | Topotecan | FDA US | Malignant Cervical Neoplasm | Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with… | ORIGNDA020671 |
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.
| openfda |
| Jan 30, 1998 | Daunorubicin | FDA US | cancer not stated in this record | Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic… | ORIGNDA050731 | approved | openfda |
| Jan 9, 1998 | Porfimer | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLNDA020451 | approved | openfda |
| Jan 9, 1998 | Aldesleukin | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLBLA103293 | approved | openfda |
| Jan 9, 1998 | Aldesleukin | FDA US | cancer not stated in this record | Efficacy supplement 1998-01-09 (see label) | SUPPLBLA103293 | approved | openfda |
| ORIGBLA103705 |
| approved |
| openfda |
| Nov 26, 1997 | Rituximab | FDA US | Non-Hodgkin Lymphoma | Adult patients with Non-Hodgkin's Lymphoma (NHL) | ORIGBLA103705 | approved | openfda |
| ORIGNDA020757 |
| approved |
| openfda |
| openfda |
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy. | ORIGNDA020726 | approved | openfda |
| Jul 25, 1997 | Letrozole | FDA US | Malignant Breast Neoplasm | Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. | ORIGNDA020726 | approved | openfda |
| Jul 8, 1997 | Sertraline | FDA US | cancer not stated in this record | Efficacy supplement 1997-07-08 (see label) | SUPPLNDA019839 | approved | openfda |
| May 29, 1997 | Toremifene | FDA US | Malignant Breast Neoplasm | FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with… | ORIGNDA020497 | approved | openfda |
| ORIGNDA020333 |
| approved |
| openfda |
| Mar 7, 1997 | Leuprolide | FDA US | cancer not stated in this record | Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. • In combination with a… | ORIGNDA020708 | approved | openfda |
| ORIGNDA050734 |
| approved |
| openfda |
| Feb 7, 1997 | Tretinoin | FDA US | cancer not stated in this record | RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A… | ORIGNDA020475 | approved | openfda |
| approved |
| openfda |
| ORIGNDA020622 |
| approved |
| openfda |
| Dec 13, 1996 | Ibuprofen | FDA US | cancer not stated in this record | USES temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020267 | approved | openfda |
| ORIGNDA020637 |
| approved |
| openfda |
| openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based… | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following… | ORIGNDA020571 | approved | openfda |
| Jun 14, 1996 | Irinotecan | FDA US | Colon Carcinoma | CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with… | ORIGNDA020571 | approved | openfda |
| Jun 10, 1996 | Ibuprofen | FDA US | cancer not stated in this record | Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches | ORIGNDA020603 | approved | openfda |
| openfda |
| May 28, 1996 | Topotecan | FDA US | Lung Small Cell Carcinoma | Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line… | ORIGNDA020671 | approved | openfda |
| May 28, 1996 | Topotecan | FDA US | Malignant Ovarian Neoplasm | Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent | ORIGNDA020671 | approved | openfda |
| May 17, 1996 | Interferon Beta-1a | FDA US | cancer not stated in this record | AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,… | ORIGBLA103628 | approved | openfda |
| May 17, 1996 | Etoposide | FDA US | cancer not stated in this record | Refractory testicular tumors, in combination with other chemotherapeutic drugs. | ORIGNDA020457 | approved | openfda |
| May 17, 1996 | Etoposide | FDA US | Lung Small Cell Carcinoma | Small cell lung cancer, in combination with cisplatin, as first-line treatment. | ORIGNDA020457 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Gastric Adenocarcinoma | Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction | ORIGNDA020449 | approved | openfda |
| May 14, 1996 | Docetaxel | FDA US | Castration-Resistant Prostate Carcinoma | Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer | ORIGNDA020449 | approved | openfda |