2016 in cancer

FDA · US: 68 records / 33 drugsHealth Canada · CA: 32 records / 19 drugsEMA · EU: 16 records / 14 drugs

• Dec 19, 2016Rucaparib FDA · US original application approved Castration-Resistant Prostate CarcinomaProstate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant…openfda
• Jul 15, 2016Nilutamide FDA · US original application approved Malignant Prostate NeoplasmMetastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Small Cell CarcinomaSmall Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Hepatocellular CarcinomaHepatocellular Carcinoma (HCC) in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Alveolar Soft Part SarcomaAlveolar Soft Part Sarcoma (ASPS) for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic ASPS.openfda
• May 18, 2016Atezolizumab FDA · US original application approved Malignant Bladder NeoplasmMuscle Invasive Bladder Cancer (MIBC) as adjuvant treatment of adult patients with MIBC after cystectomy who have circulating tumor DNA molecular residual…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Small Cell Carcinomain combination with lurbinectedin, for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Non-Small Cell Carcinomafor the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomain combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Non-Small Cell Carcinomafor the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or…openfda
• May 18, 2016Atezolizumab FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomain combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or…openfda
• May 18, 2016Atezolizumab FDA · US original application approved MelanomaMelanoma in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic…openfda
• Apr 25, 2016Cabozantinib FDA · US original application approved Hepatocellular Carcinomapatients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenibopenfda
• Apr 25, 2016Cabozantinib FDA · US original application approved Malignant Thyroid Gland Neoplasmadult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following…openfda
• Apr 25, 2016Cabozantinib FDA · US original application approved Primitive Neuroectodermal Tumoradult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic…openfda
• Apr 25, 2016Cabozantinib FDA · US original application approved Renal Cell Carcinomapatients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumabopenfda
• Apr 25, 2016Cabozantinib FDA · US original application approved Renal Cell CarcinomaCABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).openfda
• Apr 11, 2016Venetoclax FDA · US original application approved Acute Myeloid LeukemiaIn combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or…openfda
• Mar 10, 2016Melphalan FDA · US original application approved Multiple MyelomaEvomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients…openfda
• Mar 10, 2016Melphalan FDA · US original application approved Multiple MyelomaEvomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients…openfda
• Dec 19, 2016Rucaparib FDA · US original application approved cancer not stated in this recordOvarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial…openfda
• May 10, 2016Aminolevulinic Acid FDA · US original application approved cancer not stated in this record1. INDICATIONS AND USAGE AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED ® or RhodoLED ® XL lamp, a narrowband, red light illumination…openfda
• Apr 29, 2016Azacitidine FDA · US original application approved cancer not stated in this recordMyelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB)…openfda
• Apr 25, 2016Cabozantinib FDA · US original application approved cancer not stated in this recordadult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated…openfda
• Apr 11, 2016Venetoclax FDA · US original application approved cancer not stated in this recordFor the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).openfda
• Feb 23, 2016Tofacitinib FDA · US original application approved cancer not stated in this recordModerately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active psoriatic…openfda
• Nov 21, 2016Ixazomib EMA · EU centralised approved Multiple MyelomaNinlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least…ema
• Nov 9, 2016Palbociclib EMA · EU centralised approved Malignant Breast NeoplasmIbrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or…ema
• Oct 14, 2016Irinotecan EMA · EU centralised approved Pancreatic AdenocarcinomaONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult…ema
• Sep 9, 2016Cabozantinib EMA · EU centralised accelerated approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate…ema
• Aug 25, 2016Lenvatinib EMA · EU centralised accelerated approved Renal Cell CarcinomaKisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see…ema
• May 11, 2016Elotuzumab EMA · EU centralised accelerated approved Multiple MyelomaEmpliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least…ema
• Mar 16, 2016Dexamethasone EMA · EU centralised approved Multiple MyelomaTreatment of multiple myeloma.ema
• Feb 1, 2016Osimertinib EMA · EU centralised accelerated approved Lung Non-Small Cell CarcinomaTagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung…ema
• Jan 14, 2016Asparaginase EMA · EU centralised approved Acute Lymphoblastic LeukemiaSpectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients…ema
• Jan 14, 2016Pegaspargase EMA · EU centralised approved Acute Lymphoblastic LeukemiaOncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18…ema
• Dec 6, 2016Bevacizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-12-06 (see label)openfda
• Dec 4, 2016Venetoclax EMA · EU centralised approved cancer not stated in this recordVenclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib…ema
• Nov 28, 2016Ponatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-11-28 (see label)openfda
• Nov 28, 2016Filgrastim Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as GRASTOFIL (DIN 02454548) under ATC L03AA02 FILGRASTIM. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Nov 22, 2016Rituximab Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as RITUXAN SC (DIN 02457350) under ATC L01FA01 RITUXIMAB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Nov 21, 2016Daratumumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-11-21 (see label)openfda
• Nov 21, 2016Daratumumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-11-21 (see label)openfda
• Nov 10, 2016Nivolumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-11-10 (see label)openfda
• Oct 31, 2016Venetoclax Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as VENCLEXTA (DIN 02458055) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Oct 31, 2016Venetoclax Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as VENCLEXTA (DIN 02458039) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Oct 31, 2016Venetoclax Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as VENCLEXTA (DIN 02458063) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Oct 31, 2016Venetoclax Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as VENCLEXTA (DIN 02458047) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Oct 24, 2016Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-10-24 (see label)openfda
• Oct 24, 2016Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-10-24 (see label)openfda
• Oct 20, 2016Enzalutamide FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-10-20 (see label)openfda
• Oct 14, 2016Alectinib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as ALECENSARO (DIN 02458136) under ATC L01ED03 ALECTINIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Oct 12, 2016Everolimus FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-10-12 (see label)openfda
• Oct 4, 2016Nivolumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-10-04 (see label)openfda
• Sep 27, 2016Interferon Beta-1a FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2016-09-27 (see label)openfda
• Sep 22, 2016Abiraterone Acetate Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as ZYTIGA (DIN 02457113) under ATC L02BX03 ABIRATERONE. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Sep 21, 2016Ixazomib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as NINLARO (DIN 02456796) under ATC L01XG03 IXAZOMIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Sep 21, 2016Ixazomib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as NINLARO (DIN 02456826) under ATC L01XG03 IXAZOMIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Sep 21, 2016Ixazomib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as NINLARO (DIN 02456818) under ATC L01XG03 IXAZOMIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd

RegulatoryAll 2016 records with filters →

Studies

5,577

Interventional

4,430

Phase III

477

Industry-led

1,174

With posted results

1,150

Countries with sites

107

Published source: clinicaltrials · first_posted_date as posted