2011 in cancer

FDA · US: 83 records / 32 drugsEMA · EU: 11 records / 11 drugsHealth Canada · CA: 7 records / 6 drugs

• Nov 16, 2011Ruxolitinib FDA · US original application approved Polycythemia Verapolycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.openfda
• Aug 26, 2011Crizotinib FDA · US original application approved Anaplastic Large Cell Lymphomapediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.openfda
• Aug 26, 2011Crizotinib FDA · US original application approved Anaplastic Large Cell Lymphomao Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. •…openfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved Systemic Anaplastic Large Cell Lymphoma. • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimenopenfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved Classic Hodgkin LymphomaAdult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazineopenfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved Classic Hodgkin Lymphoma. • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine,…openfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved Classic Hodgkin Lymphoma. • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation…openfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved Classic Hodgkin Lymphoma. • Adult patients with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in…openfda
• Aug 17, 2011Vemurafenib FDA · US original application approved MelanomaLimitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 )openfda
• Aug 17, 2011Vemurafenib FDA · US original application approved MelanomaZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an…openfda
• Aug 4, 2011Gemcitabine FDA · US original application approved Malignant Pancreatic Neoplasmas a single agent for the treatment of pancreatic cancer.openfda
• Aug 4, 2011Gemcitabine FDA · US original application approved Lung Non-Small Cell Carcinomain combination with cisplatin for the treatment of non-small cell lung cancer.openfda
• Aug 4, 2011Gemcitabine FDA · US original application approved Malignant Breast Neoplasmin combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy,…openfda
• Aug 4, 2011Gemcitabine FDA · US original application approved Malignant Ovarian Neoplasmin combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.openfda
• Jun 29, 2011Docetaxel 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
• Jun 29, 2011Docetaxel 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
• Jun 29, 2011Docetaxel 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
• Jun 29, 2011Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate canceropenfda
• Jun 29, 2011Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Jun 8, 2011Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Jun 8, 2011Docetaxel 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
• Jun 8, 2011Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate canceropenfda
• Jun 8, 2011Docetaxel 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
• Jun 8, 2011Docetaxel 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
• May 3, 2011Docetaxel 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
• May 3, 2011Docetaxel 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
• May 3, 2011Docetaxel 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
• May 3, 2011Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate canceropenfda
• May 3, 2011Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Apr 6, 2011Vandetanib FDA · US original application approved Thyroid Gland Medullary CarcinomaCAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Hepatocellular CarcinomaHepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab.openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Esophageal Squamous Cell CarcinomaEsophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved dMMR Colorectal CarcinomaColorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved MelanomaMelanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Lung Non-Small Cell CarcinomaTreatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) • Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Cutaneous MelanomaAdjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved Pleural Malignant MesotheliomaMalignant Pleural Mesothelioma • Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with…openfda
• Mar 8, 2011Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate canceropenfda
• Mar 8, 2011Docetaxel 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
• Mar 8, 2011Docetaxel 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
• Mar 8, 2011Docetaxel 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
• Mar 8, 2011Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Feb 2, 2011Topotecan FDA · US original application approved Lung Small Cell CarcinomaTopotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60…openfda
• Nov 18, 2011Aflibercept FDA · US original application approved cancer not stated in this recordEYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration…openfda
• Nov 16, 2011Ruxolitinib FDA · US original application approved cancer not stated in this recordintermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia…openfda
• Aug 26, 2011Crizotinib FDA · US original application approved cancer not stated in this recordXALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic…openfda
• Aug 19, 2011Brentuximab Vedotin FDA · US original application approved cancer not stated in this record. • Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL),…openfda
• Aug 17, 2011Vemurafenib FDA · US original application approved cancer not stated in this recordZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation.openfda
• Apr 28, 2011Abiraterone Acetate FDA · US original application approved cancer not stated in this recordZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic…openfda
• Apr 28, 2011Abiraterone FDA · US original application approved cancer not stated in this recordZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic…openfda
• Mar 25, 2011Ipilimumab FDA · US original application approved cancer not stated in this recordin combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.openfda
• Feb 28, 2011Roflumilast FDA · US original application approved cancer not stated in this recordDALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history…openfda
• Sep 5, 2011Abiraterone EMA · EU centralised accelerated approved Castration-Resistant Prostate CarcinomaZytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or…ema
• Jul 13, 2011Temozolomide EMA · EU centralised approved GlioblastomaTemozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and…ema
• Mar 17, 2011Cabazitaxel EMA · EU centralised approved Malignant Prostate NeoplasmJevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously…ema
• Jan 6, 2011Topotecan EMA · EU centralised approved Cervical CarcinomaTopotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy-…ema
• Dec 21, 2011Lenalidomide FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2011-12-21 (see label)openfda
• Dec 13, 20115-Aminolevulinic Acid EMA · EU centralised approved cancer not stated in this recordTreatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults.…ema

RegulatoryAll 2011 records with filters →

Studies

3,708

Interventional

2,964

Phase III

384

Industry-led

982

With posted results

1,010

Countries with sites

86

Published source: clinicaltrials · first_posted_date as posted