2018 in cancer

FDA · US: 144 records / 73 drugsEMA · EU: 25 records / 20 drugsHealth Canada · CA: 22 records / 15 drugs

• Dec 21, 2018Tagraxofusp FDA · US original application approved Blastic Plasmacytoid Dendritic Cell NeoplasmELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS…openfda
• Dec 20, 2018Calaspargase Pegol FDA · US original application approved Acute Lymphoblastic LeukemiaASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia…openfda
• Dec 14, 2018Trastuzumab FDA · US original application approved Malignant Breast Neoplasmthe treatment of HER2-overexpressing breast cancer.openfda
• Dec 14, 2018Trastuzumab FDA · US original application approved Gastroesophageal Junction Adenocarcinomathe treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.openfda
• Nov 28, 2018Gilteritinib FDA · US original application approved Acute Myeloid LeukemiaXOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation…openfda
• Nov 21, 2018Glasdegib FDA · US original application approved Acute Myeloid LeukemiaDAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75…openfda
• Oct 16, 2018Talazoparib FDA · US original application approved Malignant Breast NeoplasmBreast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m)…openfda
• Oct 16, 2018Talazoparib FDA · US original application approved Castration-Resistant Prostate CarcinomaHRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR…openfda
• Sep 28, 2018Cemiplimab FDA · US original application approved Skin Squamous Cell CarcinomaCutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC…openfda
• Sep 28, 2018Cemiplimab FDA · US original application approved Basal Cell CarcinomaBasal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a…openfda
• Sep 28, 2018Cemiplimab FDA · US original application approved Lung Non-Small Cell Carcinomaas single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥50%] as…openfda
• Sep 28, 2018Cemiplimab FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung…openfda
• Sep 27, 2018Dacomitinib FDA · US original application approved Lung Non-Small Cell CarcinomaVIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)…openfda
• Sep 27, 2018Dacomitinib FDA · US original application approved Lung Non-Small Cell CarcinomaVIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)…openfda
• Aug 28, 2018Leuprolide FDA · US original application approved Malignant Prostate Neoplasm1. INDICATIONS AND USAGE LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration (leuprolide acetate) is indicated for treatment of advanced…openfda
• Jul 20, 2018Ivosidenib FDA · US original application approved Cholangiocarcinoma. Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been…openfda
• Jul 20, 2018Ivosidenib FDA · US original application approved Acute Myeloid LeukemiaNewly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or…openfda
• Jul 20, 2018Ivosidenib FDA · US original application approved Myelodysplastic Syndrome. Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromesopenfda
• Jun 27, 2018Encorafenib FDA · US original application approved Lung Non-Small Cell CarcinomaNon-Small Cell Lung Cancer (NSCLC) • in combination with binimetinib, for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC)…openfda
• Jun 27, 2018Encorafenib FDA · US original application approved Malignant Colorectal NeoplasmColorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal…openfda
• Jun 27, 2018Encorafenib FDA · US original application approved MelanomaMelanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as…openfda
• Jun 27, 2018Binimetinib FDA · US original application approved Melanomain combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an…openfda
• Jun 27, 2018Binimetinib FDA · US original application approved Lung Non-Small Cell Carcinomain combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected…openfda
• May 22, 2018Abiraterone FDA · US original application approved Castration-Resistant Prostate CarcinomaAbiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.…openfda
• May 22, 2018Abiraterone Acetate FDA · US original application approved Castration-Resistant Prostate CarcinomaAbiraterone Acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer.…openfda
• May 15, 2018Bendamustine 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
• May 15, 2018Bendamustine 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
• Feb 16, 2018Ibrutinib FDA · US original application approved Waldenstrom Macroglobulinemia. Adult patients with Waldenström’s macroglobulinemia (WM)openfda
• Feb 16, 2018Ibrutinib FDA · US original application approved Waldenstrom Macroglobulinemia. Adult patients with Waldenström’s macroglobulinemia (WM)openfda
• Feb 14, 2018Apalutamide FDA · US original application approved Nonmetastatic Castration-Resistant Prostate CarcinomaERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate…openfda
• Dec 14, 2018Trastuzumab FDA · US original application approved cancer not stated in this recordSelect patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ( 1 , 2.2 )openfda
• Nov 30, 2018Dexamethasone FDA · US original application approved cancer not stated in this recordThe treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients. • . The treatment of ocular itching associated…openfda
• Nov 26, 2018Larotrectinib FDA · US original application approved tumor-agnosticVITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene…openfda
• Nov 26, 2018Larotrectinib FDA · US original application approved tumor-agnosticVITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene…openfda
• Nov 2, 2018Lorlatinib FDA · US original application approved cancer not stated in this recordLORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase…openfda
• Oct 19, 2018Levoleucovorin FDA · US original application approved cancer not stated in this recordKHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated…openfda
• Sep 28, 2018Cemiplimab FDA · US original application approved cancer not stated in this recordfor the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.openfda
• Sep 24, 2018Duvelisib FDA · US original application approved cancer not stated in this recordCOPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)…openfda
• Sep 24, 2018Duvelisib FDA · US original application approved cancer not stated in this recordCOPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)…openfda
• Aug 31, 2018Arsenic Trioxide FDA · US original application approved cancer not stated in this recordFor induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and…openfda
• Aug 23, 2018Tretinoin FDA · US original application approved cancer not stated in this recordALTRENO ® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid…openfda
• Aug 8, 2018Mogamulizumab FDA · US original application approved cancer not stated in this recordPOTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior…openfda
• Jul 20, 2018Ivosidenib FDA · US original application approved cancer not stated in this record. Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AMLopenfda
• Jun 27, 2018Encorafenib FDA · US original application approved cancer not stated in this recordin combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior…openfda
• Feb 16, 2018Ibrutinib 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
• Feb 16, 2018Ibrutinib 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
• Sep 26, 2018Abemaciclib EMA · EU centralised approved Malignant Breast NeoplasmEarly Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)…ema
• Aug 31, 2018Neratinib EMA · EU centralised approved Malignant Breast NeoplasmNerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast…ema
• May 23, 2018Rucaparib EMA · EU centralised approved Malignant Peritoneal NeoplasmRubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian,…ema
• Apr 19, 2018Gemtuzumab Ozogamicin EMA · EU centralised approved Acute Promyelocytic LeukemiaMylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with…ema
• Jan 8, 2018Fulvestrant EMA · EU centralised approved Malignant Breast NeoplasmFulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously…ema
• Dec 28, 2018Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-28 (see label)openfda
• Dec 21, 2018Brigatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-21 (see label)openfda
• Dec 21, 2018Dasatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-21 (see label)openfda
• Dec 19, 2018Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-19 (see label)openfda
• Dec 19, 2018Olaparib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-19 (see label)openfda
• Dec 12, 2018Trastuzumab EMA · EU centralised approved cancer not stated in this recordBreast cancer Metastatic breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as…ema
• Dec 6, 2018Lapatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-06 (see label)openfda
• Dec 6, 2018Atezolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-12-06 (see label)openfda
• Nov 30, 2018Crizotinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2018-11-30 (see label)openfda

RegulatoryAll 2018 records with filters →

Studies

6,212

Interventional

4,832

Phase III

509

Industry-led

1,394

With posted results

1,162

Countries with sites

109

Published source: clinicaltrials · first_posted_date as posted