2014 in cancer

FDA · US: 112 records / 38 drugsHealth Canada · CA: 32 records / 17 drugsEMA · EU: 11 records / 11 drugs

• Dec 22, 2014Nivolumab FDA · US original application approved Malignant Esophageal NeoplasmEsophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Lung Non-Small Cell Carcinomaadult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Urothelial Carcinomaadult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. •…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Renal Cell Carcinomaadult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Lung Non-Small Cell Carcinomaadult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Head and Neck Squamous Cell Carcinomaautologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT.…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Lung Non-Small Cell Carcinomaadult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Melanomafor the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Lung Non-Small Cell Carcinomaadult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Esophageal Squamous Cell Carcinomaadult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Classic Hodgkin LymphomaClassical Hodgkin Lymphoma (cHL) • adult and pediatric (12 years and older) patients with previously untreated, Stage III or IV classical Hodgkin lymphoma in…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Esophageal Squamous Cell Carcinomaadult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Esophageal Squamous Cell Carcinomaadult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved dMMR Colorectal CarcinomaColorectal Cancer • adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Urothelial CarcinomaUrothelial Carcinoma • adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Urothelial Carcinomaadult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Hepatocellular CarcinomaHepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Renal Cell Carcinomaadult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Classic Hodgkin Lymphomaadult patients with classical Hodgkin lymphoma that has relapsed or progressed after:openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Pleural Malignant MesotheliomaMalignant Pleural Mesothelioma • adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Malignant Colorectal Neoplasmadult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer…openfda
• Dec 22, 2014Nivolumab FDA · US original application approved MelanomaMelanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab.openfda
• Dec 22, 2014Nivolumab FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in…openfda
• Dec 3, 2014Blinatumomab FDA · US original application approved Acute Lymphoblastic LeukemiaCD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.openfda
• Dec 3, 2014Blinatumomab FDA · US original application approved Acute Lymphoblastic LeukemiaCD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or…openfda
• Dec 3, 2014Blinatumomab FDA · US original application approved Acute Lymphoblastic LeukemiaRelapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Primary Mediastinal Large B-Cell LymphomaPrimary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Cervical NeoplasmCervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved MelanomaMelanoma for the treatment of patients with unresectable or metastatic melanoma.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell Carcinomaas a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Classic Hodgkin LymphomaClassical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Pleural Malignant MesotheliomaMalignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Endometrial Carcinomaas a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Endometrial CarcinomaEndometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Clear Cell Renal Cell Carcinomain combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Biliary Tract NeoplasmBiliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Triple-Negative Breast Carcinomain combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Non-Muscle Invasive Bladder Carcinomaas a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Cervical Neoplasmas a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Cervical Neoplasmin combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Gastric NeoplasmGastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved dMMR Colorectal CarcinomaMicrosatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Malignant Bladder Neoplasmin combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Hepatocellular CarcinomaHepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Urothelial Carcinomaas a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Head and Neck Squamous Cell Carcinomaas a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Endometrial Carcinomain combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Head and Neck Squamous Cell Carcinomaas a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Triple-Negative Breast Carcinomain combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell Carcinomafor the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Melanomafor the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Triple-Negative Breast CarcinomaTriple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment,…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell Carcinomaas a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell Carcinomaas a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized…openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Lung Non-Small Cell Carcinomain combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.openfda
• Sep 4, 2014Pembrolizumab FDA · US original application approved Head and Neck Squamous Cell Carcinomain combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.openfda

RegulatoryAll 2014 records with filters →

Studies

4,521

Interventional

3,681

Phase III

409

Industry-led

1,139

With posted results

1,142

Countries with sites

95

Published source: clinicaltrials · first_posted_date as posted