2015 in cancer

FDA · US: 80 records / 48 drugsHealth Canada · CA: 29 records / 16 drugsEMA · EU: 15 records / 14 drugs

• Dec 11, 2015Alectinib FDA · US original application approved Lung Non-Small Cell Carcinomatreatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.openfda
• Dec 7, 2015Bendamustine FDA · US original application approved Chronic Lymphocytic LeukemiaChronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.openfda
• Dec 7, 2015Bendamustine FDA · US original application approved Indolent B-Cell Non-Hodgkin LymphomaIndolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.openfda
• Nov 30, 2015Elotuzumab FDA · US original application approved Multiple Myelomacombination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1)openfda
• Nov 30, 2015Elotuzumab FDA · US original application approved Multiple MyelomaEMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to…openfda
• Nov 30, 2015Elotuzumab FDA · US original application approved Multiple MyelomaEMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least…openfda
• Nov 30, 2015Elotuzumab FDA · US original application approved Multiple Myelomacombination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies…openfda
• Nov 20, 2015Ixazomib FDA · US original application approved Multiple MyelomaNINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one…openfda
• Nov 16, 2015Daratumumab FDA · US original application approved Multiple MyelomaDARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients…openfda
• Nov 13, 2015Osimertinib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or…openfda
• Nov 13, 2015Osimertinib FDA · US original application approved Lung Non-Small Cell Carcinomaadjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon…openfda
• Nov 13, 2015Osimertinib Mesylate FDA · US original application approved Lung Non-Small Cell Carcinomathe first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an…openfda
• Nov 13, 2015Osimertinib Mesylate FDA · US original application approved Lung Non-Small Cell Carcinomaadjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon…openfda
• Nov 13, 2015Osimertinib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or…openfda
• Nov 13, 2015Osimertinib Mesylate FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or…openfda
• Nov 13, 2015Osimertinib Mesylate FDA · US original application approved Lung Non-Small Cell Carcinomain combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose…openfda
• Nov 13, 2015Osimertinib FDA · US original application approved Lung Non-Small Cell Carcinomain combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose…openfda
• Nov 13, 2015Osimertinib Mesylate FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or…openfda
• Nov 13, 2015Osimertinib FDA · US original application approved Lung Non-Small Cell Carcinomathe first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an…openfda
• Nov 10, 2015Cobimetinib FDA · US original application approved MelanomaFor the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.openfda
• Oct 22, 2015Irinotecan FDA · US original application approved Pancreatic AdenocarcinomaONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic…openfda
• Aug 28, 2015Erlotinib FDA · US original application approved Lung Non-Small Cell CarcinomaThe treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or…openfda
• Aug 28, 2015Erlotinib FDA · US original application approved Lung Non-Small Cell CarcinomaLimitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations.openfda
• Aug 28, 2015Erlotinib FDA · US original application approved Malignant Pancreatic NeoplasmFirst-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.openfda
• Jul 24, 2015Sonidegib FDA · US original application approved Basal Cell CarcinomaODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or…openfda
• Jul 13, 2015Gefitinib FDA · US original application approved Lung Non-Small Cell CarcinomaIRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor…openfda
• Mar 10, 2015Dinutuximab FDA · US original application approved High Risk NeuroblastomaUnituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic…openfda
• Feb 13, 2015Lenvatinib FDA · US original application approved Endometrial CarcinomaEndometrial Carcinoma (EC) In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair…openfda
• Feb 13, 2015Lenvatinib FDA · US original application approved Renal Cell CarcinomaIn combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.openfda
• Feb 13, 2015Lenvatinib FDA · US original application approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC).openfda
• Feb 13, 2015Lenvatinib FDA · US original application approved Hepatocellular CarcinomaHepatocellular Carcinoma (HCC) For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).openfda
• Feb 13, 2015Lenvatinib FDA · US original application approved Malignant Thyroid Gland NeoplasmDifferentiated Thyroid Cancer (DTC) For the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory…openfda
• Feb 3, 2015Palbociclib FDA · US original application approved Malignant Breast Neoplasmin combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative,…openfda
• Feb 3, 2015Palbociclib FDA · US original application approved Malignant Breast Neoplasmfor the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast…openfda
• Feb 3, 2015Palbociclib FDA · US original application approved Malignant Breast Neoplasmin combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2…openfda
• Dec 11, 2015Alectinib FDA · US original application approved cancer not stated in this recordadjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm…openfda
• Nov 10, 2015Cobimetinib FDA · US original application approved cancer not stated in this recordAs a single agent for the treatment of adult patients with histiocytic neoplasms.openfda
• Oct 23, 2015Trabectedin FDA · US original application approved cancer not stated in this recordYONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior…openfda
• Sep 18, 2015Fluorouracil FDA · US original application approved cancer not stated in this recordTolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak (fluorouracil) Cream, 4%,…openfda
• Aug 28, 2015Erlotinib FDA · US original application approved cancer not stated in this recordErlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.openfda
• Feb 3, 2015Palbociclib FDA · US original application approved cancer not stated in this record; or o fulvestrant in patients with disease progression following endocrine therapy.openfda
• Dec 16, 2015Talimogene Laherparepvec EMA · EU centralised approved MelanomaImlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no…ema
• Nov 23, 2015Blinatumomab EMA · EU centralised approved Acute Lymphoblastic LeukemiaBlincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia…ema
• Nov 20, 2015Cobimetinib EMA · EU centralised approved MelanomaCotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600…ema
• Nov 19, 2015Carfilzomib EMA · EU centralised accelerated approved Multiple MyelomaKyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of…ema
• Aug 28, 2015Panobinostat EMA · EU centralised approved Multiple MyelomaFarydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma…ema
• Aug 14, 2015Sonidegib EMA · EU centralised approved Basal Cell CarcinomaOdomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation…ema
• Dec 18, 2015Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-12-18 (see label)openfda
• Dec 18, 2015Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-12-18 (see label)openfda
• Dec 17, 2015Oxaliplatin Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as OXALIPLATIN (DIN 02444763) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Dec 17, 2015Oxaliplatin Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as OXALIPLATIN INJECTION (DIN 02436957) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Dec 16, 2015Oxaliplatin Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as OXALIPLATIN INJECTION (DIN 02435071) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Dec 8, 2015Temozolomide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02441160) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Nov 26, 2015Pemetrexed EMA · EU centralised approved cancer not stated in this recordMalignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable…ema
• Nov 23, 2015Nivolumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-11-23 (see label)openfda
• Nov 23, 2015Nivolumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-11-23 (see label)openfda
• Nov 20, 2015Trametinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-11-20 (see label)openfda
• Nov 20, 2015Ibuprofen FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-11-20 (see label)openfda
• Nov 20, 2015Dabrafenib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2015-11-20 (see label)openfda
• Nov 19, 2015Cinacalcet EMA · EU centralised approved cancer not stated in this recordTreatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used…ema

RegulatoryAll 2015 records with filters →

Studies

4,926

Interventional

4,030

Phase III

489

Industry-led

1,162

With posted results

1,157

Countries with sites

94

Published source: clinicaltrials · first_posted_date as posted