2017 in cancer

FDA · US: 130 records / 63 drugsHealth Canada · CA: 28 records / 19 drugsEMA · EU: 18 records / 15 drugs

• Nov 9, 2017Dactinomycin FDA · US original application approved Malignant Testicular Neoplasmadult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen.openfda
• Nov 9, 2017Dactinomycin FDA · US original application approved Wilms Tumoradult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.openfda
• Nov 9, 2017Dactinomycin FDA · US original application approved Rhabdomyosarcomaadult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen.openfda
• Nov 9, 2017Dactinomycin FDA · US original application approved Ewing Sarcomaadult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen.openfda
• Oct 31, 2017Acalabrutinib FDA · US original application approved Mantle Cell LymphomaIn combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for…openfda
• Sep 28, 2017Abemaciclib FDA · US original application approved Malignant Breast Neoplasmas monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following…openfda
• Sep 28, 2017Abemaciclib FDA · US original application approved Malignant Breast Neoplasmin combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human…openfda
• Sep 28, 2017Abemaciclib FDA · US original application approved Malignant Breast Neoplasmin combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive,…openfda
• Sep 28, 2017Abemaciclib FDA · US original application approved Malignant Breast Neoplasmin combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2…openfda
• Sep 1, 2017Gemtuzumab Ozogamicin FDA · US original application approved Acute Myeloid Leukemiatreatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and olderopenfda
• Sep 1, 2017Gemtuzumab Ozogamicin FDA · US original application approved Acute Myeloid Leukemiatreatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and olderopenfda
• Aug 17, 2017Olaparib FDA · US original application approved Pancreatic AdenocarcinomaPancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma…openfda
• Aug 17, 2017Inotuzumab Ozogamicin FDA · US original application approved Acute Lymphoblastic Leukemia1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Hormone Receptor-Positive Breast Carcinomafor the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Malignant Breast NeoplasmBreast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Malignant Peritoneal Neoplasmin combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Castration-Resistant Prostate CarcinomaProstate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR)…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Castration-Resistant Prostate Carcinomain combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated (…openfda
• Aug 17, 2017Olaparib FDA · US original application approved Malignant Peritoneal Neoplasmfor the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian,…openfda
• Aug 3, 2017Gemcitabine 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 3, 2017Gemcitabine 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
• Aug 3, 2017Gemcitabine FDA · US original application approved Malignant Pancreatic Neoplasmas a single agent for the treatment of pancreatic cancer.openfda
• Aug 3, 2017Gemcitabine FDA · US original application approved Lung Non-Small Cell Carcinomain combination with cisplatin for the treatment of non-small cell lung cancer.openfda
• Aug 1, 2017Enasidenib FDA · US original application approved Acute Myeloid LeukemiaIDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with…openfda
• Jul 17, 2017Neratinib FDA · US original application approved HER2-Positive Breast CarcinomaIn combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more…openfda
• Jul 17, 2017Neratinib FDA · US original application approved HER2-Positive Breast CarcinomaAs a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based…openfda
• Jun 29, 2017Triptorelin FDA · US original application approved Conventional OsteosarcomaTRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin…openfda
• May 1, 2017Durvalumab FDA · US original application approved Gastroesophageal Junction Adenocarcinomain combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent…openfda
• May 1, 2017Durvalumab FDA · US original application approved Malignant Bladder Neoplasmin combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy,…openfda
• May 1, 2017Durvalumab FDA · US original application approved Malignant Biliary Tract Neoplasmin combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).openfda
• May 1, 2017Durvalumab FDA · US original application approved Lung Small Cell Carcinomain combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer…openfda
• May 1, 2017Durvalumab FDA · US original application approved Lung Small Cell Carcinomaas a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following…openfda
• May 1, 2017Durvalumab FDA · US original application approved Lung Non-Small Cell Carcinomain combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR…openfda
• May 1, 2017Durvalumab FDA · US original application approved Lung Non-Small Cell Carcinomaas a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based…openfda
• May 1, 2017Durvalumab FDA · US original application approved Hepatocellular Carcinomain combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).openfda
• May 1, 2017Durvalumab FDA · US original application approved Non-Muscle Invasive Bladder Carcinomain combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).openfda
• May 1, 2017Durvalumab FDA · US original application approved Malignant Endometrial Neoplasmin combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent…openfda
• Apr 28, 2017Midostaurin FDA · US original application approved Acute Myeloid LeukemiaNewly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and…openfda
• Apr 28, 2017Midostaurin FDA · US original application approved Acute Myeloid LeukemiaNewly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and…openfda
• Apr 25, 2017Methotrexate FDA · US original application approved Acute Lymphoblastic LeukemiaTreatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimenopenfda
• Apr 25, 2017Methotrexate FDA · US original application approved Acute Lymphoblastic LeukemiaTreatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimenopenfda
• Mar 23, 2017Avelumab FDA · US original application approved Renal Cell CarcinomaRenal Cell Carcinoma (RCC) First-line treatment, in combination with axitinib, of patients with advanced RCC.openfda
• Mar 23, 2017Avelumab FDA · US original application approved Urothelial CarcinomaUrothelial Carcinoma (UC) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing…openfda
• Mar 23, 2017Avelumab FDA · US original application approved Merkel Cell CarcinomaMerkel Cell Carcinoma (MCC) Adults and pediatric patients 12 years and older with metastatic MCC.openfda
• Mar 13, 2017Ribociclib FDA · US original application approved Malignant Breast NeoplasmEarly Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive,…openfda
• Mar 13, 2017Ribociclib FDA · US original application approved Malignant Breast NeoplasmAdvanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in…openfda
• Jan 26, 2017Thiotepa FDA · US original application approved Bladder CarcinomaFor treatment of superficial papillary carcinoma of the urinary bladder.openfda
• Jan 26, 2017Thiotepa FDA · US original application approved Gastric Diffuse AdenocarcinomaFor controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.openfda
• Jan 26, 2017Thiotepa FDA · US original application approved Breast AdenocarcinomaFor treatment of adenocarcinoma of the breast or ovary.openfda
• Dec 21, 2017Hydroxyurea FDA · US original application approved cancer not stated in this recordSIKLOS ® is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age…openfda
• Nov 9, 2017Dactinomycin FDA · US original application approved cancer not stated in this recordpost-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. • adult patients with…openfda
• Oct 31, 2017Acalabrutinib FDA · US original application approved cancer not stated in this recordFor the treatment of adult patients with MCL who have received at least one prior therapy. • For the treatment of adult patients with chronic lymphocytic…openfda
• Sep 1, 2017Gemtuzumab Ozogamicin FDA · US original application approved cancer not stated in this record. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and olderopenfda
• Sep 1, 2017Gemtuzumab Ozogamicin FDA · US original application approved cancer not stated in this record. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and olderopenfda
• Aug 17, 2017Olaparib FDA · US original application approved cancer not stated in this recordOvarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced…openfda
• Jun 6, 2017Aminolevulinic Acid FDA · US original application approved cancer not stated in this recordGleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the…openfda
• May 9, 2017Clofarabine FDA · US original application approved cancer not stated in this recordOriginal approval 2017-05-09 — label text not available on openFDAopenfda
• May 1, 2017Durvalumab FDA · US original application approved cancer not stated in this recordin combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after…openfda
• Apr 28, 2017Midostaurin FDA · US original application approved cancer not stated in this recordLimitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM),…openfda
• Apr 28, 2017Brigatinib FDA · US original application approved cancer not stated in this recordALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as…openfda

RegulatoryAll 2017 records with filters →

Studies

5,807

Interventional

4,609

Phase III

451

Industry-led

1,182

With posted results

1,196

Countries with sites

112

Published source: clinicaltrials · first_posted_date as posted