2013 in cancer

FDA · US: 60 records / 30 drugsHealth Canada · CA: 30 records / 20 drugsEMA · EU: 14 records / 13 drugs

• Nov 13, 2013Ibrutinib FDA · US original application approved Waldenstrom Macroglobulinemia. Adult patients with Waldenström’s macroglobulinemia (WM)openfda
• Nov 1, 2013Obinutuzumab FDA · US original application approved Chronic Lymphocytic Leukemiain combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).openfda
• Nov 1, 2013Obinutuzumab FDA · US original application approved Follicular Lymphomain combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with…openfda
• Nov 1, 2013Obinutuzumab FDA · US original application approved Follicular Lymphomain combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are…openfda
• Aug 23, 2013Mechlorethamine FDA · US original application approved Mycosis FungoidesVALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior…openfda
• Jul 12, 2013Afatinib FDA · US original application approved Lung Non-Small Cell CarcinomaTreatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapyopenfda
• Jul 12, 2013Afatinib FDA · US original application approved Lung Non-Small Cell CarcinomaFirst-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR)…openfda
• May 29, 2013Trametinib FDA · US original application approved MelanomaMEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic…openfda
• May 29, 2013Dabrafenib FDA · US original application approved MelanomaTAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K…openfda
• May 29, 2013Dabrafenib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.openfda
• May 29, 2013Dabrafenib FDA · US original application approved Thyroid Gland Anaplastic Carcinomathe treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test,…openfda
• May 29, 2013Dabrafenib FDA · US original application approved MelanomaTAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as…openfda
• May 29, 2013Trametinib FDA · US original application approved MelanomaMEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K…openfda
• May 29, 2013Trametinib FDA · US original application approved Melanomathe adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s),…openfda
• May 29, 2013Trametinib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.openfda
• May 29, 2013Trametinib FDA · US original application approved Thyroid Gland Anaplastic Carcinomathe treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test,…openfda
• May 29, 2013Trametinib FDA · US original application approved Malignant Colorectal NeoplasmLimitations of Use : MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.openfda
• May 29, 2013Dabrafenib FDA · US original application approved Malignant Colorectal NeoplasmLimitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.openfda
• May 29, 2013Dabrafenib FDA · US original application approved Melanomathe adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s),…openfda
• May 15, 2013Radium Ra-223 Dichloride FDA · US original application approved Castration-Resistant Prostate CarcinomaXofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic…openfda
• Apr 12, 2013Docetaxel FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable,…openfda
• Apr 12, 2013Docetaxel FDA · US original application approved Malignant Breast NeoplasmBreast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant…openfda
• Apr 12, 2013Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Apr 12, 2013Docetaxel FDA · US original application approved Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHNopenfda
• Apr 12, 2013Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate canceropenfda
• Feb 22, 2013Trastuzumab Emtansine FDA · US original application approved Malignant Breast Neoplasmthe adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based…openfda
• Feb 22, 2013Trastuzumab Emtansine FDA · US original application approved Malignant Breast Neoplasmthe treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients…openfda
• Feb 8, 2013Pomalidomide FDA · US original application accelerated approved AIDS-Related Kaposi Sarcoma. • with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This…openfda
• Feb 8, 2013Pomalidomide FDA · US original application approved Multiple Myelomain combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a…openfda
• Nov 13, 2013Ibrutinib FDA · US original application approved cancer not stated in this recordAdult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) • . Adult patients with chronic lymphocytic leukemia (CLL)/Small…openfda
• Nov 1, 2013Obinutuzumab FDA · US original application approved cancer not stated in this recordfor the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapyopenfda
• Oct 11, 2013Methotrexate FDA · US original application approved cancer not stated in this recordManagement of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an…openfda
• Oct 11, 2013Methotrexate FDA · US original application approved cancer not stated in this recordManagement of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an…openfda
• Sep 16, 2013Cyclophosphamide FDA · US original application approved cancer not stated in this recordMalignant Diseases : malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple…openfda
• Aug 2, 2013Zoledronic Acid FDA · US original application approved cancer not stated in this recordHypercalcemia of malignancy. • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard…openfda
• Jul 12, 2013Afatinib FDA · US original application approved cancer not stated in this recordLimitations of Use : Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutationsopenfda
• May 29, 2013Trametinib FDA · US original application accelerated approved tumor-agnosticthe treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed…openfda
• May 29, 2013Dabrafenib FDA · US original application accelerated approved tumor-agnosticthe treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed…openfda
• Feb 22, 2013Trastuzumab Emtansine FDA · US original application approved cancer not stated in this recordSelect patients for therapy based on an FDA-authorized test for KADCYLA [see Dosage and Administration (2.1) ]openfda
• Nov 15, 2013Trastuzumab Emtansine EMA · EU centralised approved Malignant Breast NeoplasmEarly Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have…ema
• Nov 13, 2013Radium Ra223 dichloride EMA · EU centralised approved Castration-Resistant Prostate CarcinomaXofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.ema
• Sep 25, 2013Afatinib EMA · EU centralised approved Lung Non-Small Cell CarcinomaGiotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic…ema
• Aug 5, 2013Pomalidomide EMA · EU centralised approved Multiple MyelomaImnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one…ema
• Jul 12, 2013Vismodegib EMA · EU centralised approved Basal Cell CarcinomaErivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma…ema
• Jun 21, 2013Enzalutamide EMA · EU centralised approved Castration-Resistant Prostate CarcinomaXtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent…ema
• Mar 27, 2013Bosutinib EMA · EU centralised approved Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 PositiveBosulif is indicated for the treatment of:• Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia…ema
• Mar 4, 2013Pertuzumab EMA · EU centralised approved Early Stage Breast CarcinomaMetastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally…ema
• Feb 1, 2013Aflibercept EMA · EU centralised approved Malignant Colorectal NeoplasmTreatment of metastatic colorectal cancer (MCRC).ema
• Dec 10, 2013Capecitabine FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-12-10 (see label)openfda
• Dec 2, 2013Exemestane Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as MED-EXEMESTANE (DIN 02407841) under ATC L02BG06 EXEMESTANE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Nov 27, 2013Mercaptopurine Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as MERCAPTOPURINE TABLETS USP (DIN 02415275) under ATC L01BB02 MERCAPTOPURINE. Indications are not published in the Drug Product Database —…health-canada-dpd
• Nov 22, 2013Sorafenib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-22 (see label)openfda
• Nov 22, 2013Sorafenib Tosylate FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-22 (see label)openfda
• Nov 21, 2013Topotecan Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TOPOTECAN HYDROCHLORIDE FOR INJECTION (DIN 02396378) under ATC L01CE01 TOPOTECAN. Indications are not published in the Drug Product…health-canada-dpd
• Nov 20, 2013Crizotinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-20 (see label)openfda
• Nov 18, 2013Tofacitinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-18 (see label)openfda
• Nov 6, 2013Everolimus FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-06 (see label)openfda
• Nov 6, 2013Everolimus FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-11-06 (see label)openfda
• Oct 18, 2013Lapatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-10-18 (see label)openfda
• Oct 18, 2013Lapatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2013-10-18 (see label)openfda

RegulatoryAll 2013 records with filters →

Studies

4,048

Interventional

3,312

Phase III

399

Industry-led

931

With posted results

1,046

Countries with sites

101

Published source: clinicaltrials · first_posted_date as posted