当前位置： SCI文献检索 > INVESTIGATIONAL NEW DRUGS期刊下所有文献 > Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin.

Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin.

Abstract：

:Major discrepancies concerning risk-benefit assessments and regulatory actions are frequent among regulatory agencies. We explored the differences by scrutinizing a case of gemtuzumab ozogamicin (GO) in patients with acute myeloid leukaemia (AML). Assessment reports of GO were retrieved form the websites of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japanese regulatory agency, and we also reviewed published clinical trials. While GO was approved by the US FDA under the accelerated approval program in 2000, it was withdrawn from the market in 2010, based on the required post-marketing commitment failure. The EMA refused granting marketing authorization for GO in 2008 on the grounds that there were no randomised controlled trials (RCTs). GO was approved as an orphan drug in Japan in 2005, and the Japanese regulatory authority decided to continue with the approval in 2010 on the condition that post-marketing surveillance is strengthened. Under these situations, promising new results of RCTs appeared in 2011, and the role of GO in AML treatment was refocused worldwide. The stringent regulation may not be suitable in case of an orphan drug of targeted therapy, and more room should be kept to facilitate effective developments of new anti-neoplastic agents.

journal_name

Invest New Drugs

journal_title

Investigational new drugs

authors

Tanimoto T,Tsubokura M,Mori J,Pietrek M,Ono S,Kami M

doi

10.1007/s10637-012-9877-8

subject

Has Abstract

pub_date

2013-04-01 00:00:00

pages

473-8

issue

2

eissn

0167-6997

issn

1573-0646

journal_volume

31

pub_type

杂志文章,评审

相关文献

INVESTIGATIONAL NEW DRUGS文献大全
  • Activity of the polyamine-vectorized anti-cancer drug F14512 against pediatric glioma and neuroblastoma cell lines.

    abstract：:The poor prognosis of children with high-grade glioma (HGG) and high-risk neuroblastoma, despite multidisciplinary therapeutic approaches, demands new treatments for these indications. F14512 is a topoisomerase II inhibitor containing a spermine moiety that facilitates selective uptake by tumor cells via the Polyamine...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-014-0132-3

    authors： Leblond P,Boulet E,Bal-Mahieu C,Pillon A,Kruczynski A,Guilbaud N,Bailly C,Sarrazin T,Lartigau E,Lansiaux A,Meignan S

    更新日期：2014-10-01 00:00:00

  • Synthesis, characterization, and evaluation of Cd[L-proline]2, a novel histone deacetylase inhibitor that induces epigenetic modification of histone deacetylase isoforms in A549 cells.

    abstract：:Histone deacetylases (HDACs) play an important role in the epigenetic regulation of gene expression through their effects on the compact chromatin structure. In clinical studies, several classes of histone deacetylase inhibitors (HDACi) have demonstrated potent anticancer activities with metal complexes. Hence, we syn...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-017-0489-1

    authors： Chidambaram A,Sekar A,S H K,Chidambaram RK,Arunachalam K,G P S,Vilwanathan R

    更新日期：2017-12-01 00:00:00

  • High-dose aminothiadiazole in advanced colorectal cancer. An Illinois Cancer Center phase II trial.

    abstract：:Thirty-three patients with advanced colorectal carcinoma were entered on a phase II trial of weekly IV aminothiadiazole (175 mg/m2 escalated to 200 mg/m2) with concomitant allopurinol and non-steroidal anti-inflammatory agents (NSAID's). Toxicity was predominantly GI, cutaneous, and chest pain/dyspnea. Twenty-five per...

    journal_title：Investigational new drugs

    pub_type： 临床试验,杂志文章

    doi：10.1007/BF00873044

    authors： Locker GY,Kilton L,Khandekar JD,Lad TE,Knop RH,Albain K,Blough R,French S,Benson AB 3rd

    更新日期：1994-01-01 00:00:00

  • Phase I dose escalation and pharmacokinetic evaluation of two different schedules of LY2334737, an oral gemcitabine prodrug, in patients with advanced solid tumors.

    abstract：BACKGROUND:This Phase-I-study aimed to determine the recommended Phase-II-dosing-schedule of LY2334737, an oral gemcitabine prodrug, in patients with advanced/metastatic solid tumors. Pharmacokinetics, cytokeratin-18 (CK18) levels, genetic polymorphisms, and antitumor activity were additionally evaluated. METHODS:Pati...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-015-0286-7

    authors： Faivre SJ,Olszanski AJ,Weigang-Köhler K,Riess H,Cohen RB,Wang X,Myrand SP,Wickremsinhe ER,Horn CL,Ouyang H,Callies S,Benhadji KA,Raymond E

    更新日期：2015-12-01 00:00:00

  • Phase II study of esorubicin (4'-deoxydoxorubicin) in advanced epithelial carcinoma of the ovary: a Gynecologic Oncology Group study.

    abstract：:Twenty-six patients with advanced, measurable epithelial carcinoma of the ovary were treated with 76 courses of esorubicin at doses ranging from 20-30 mg/m2 every 3 weeks. All patients are evaluable for toxicity and response. All patients had received prior therapy including radiation therapy in 9, non-anthracycline c...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/BF00173763

    authors： McGuire WP,Blessing JA,Berman ML

    更新日期：1989-11-01 00:00:00

  • Early depth of tumor shrinkage and treatment outcomes in non-small cell lung cancer treated using Nivolumab.

    abstract：:Background It would be useful to have criteria for predicting long-term treatment responses to immune checkpoint inhibitors (ICIs). Maximum depth of response correlates with treatment outcomes among patients receiving programmed death protein 1 axis inhibitors for non-small cell lung cancer (NSCLC). We investigated as...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-019-00770-y

    authors： Kawachi H,Fujimoto D,Morimoto T,Hosoya K,Sato Y,Kogo M,Nagata K,Nakagawa A,Tachikawa R,Tomii K

    更新日期：2019-12-01 00:00:00

  • Phase II trial of 4' deoxydoxorubicin (DXDX) for unresectable non-small cell bronchogenic carcinoma. An Illinois Cancer Council study.

    abstract：:A phase II trial of 4' Deoxydoxorubicin (DXDX) was conducted in unresectable previously untreated non-small cell lung cancer patients. DXDX was administered every 3 weeks by short intravenous infusion at a starting dose of 30 mg/m2, with dose escalation to 40 mg/m2 toxicity permitting. Four responses, all partial, wer...

    journal_title：Investigational new drugs

    pub_type： 临床试验,杂志文章,多中心研究

    doi：10.1007/BF00216932

    authors： Rose C,Lad TE,Kilton LJ,Schor J,Rosen ST,Rossof AH,Blough RR,Johnson CM

    更新日期：1990-02-01 00:00:00

  • Novel palladium (II) complexes with tetradentate thiosemicarbazones. Synthesis, characterization, in vitro cytotoxicity and xanthine oxidase inhibition.

    abstract：:In vitro cytotoxicity and xanthine oxidase inhibition capabilities were investigated for five palladium (II) chelate complexes. The palladium complexes were synthesized by starting from S-alkyl-thiosemicarbazones where the alkyl component is methyl, ethyl, propyl or butyl. The solid complexes are characterized by elem...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-019-00751-1

    authors： Özerkan D,Ertik O,Kaya B,Kuruca SE,Yanardag R,Ülküseven B

    更新日期：2019-12-01 00:00:00

  • Continuing pursuit for ideal systemic anticancer radiotherapeutics.

    abstract：:Cancer is one of the major causes of death for non-transmissible chronic diseases worldwide. Conventional treatments including surgery, chemotherapy and external beam radiotherapy are generally far from curative. Complementary therapies are attempted for achieving more successful treatment response. Systemic targeted ...

    journal_title：Investigational new drugs

    pub_type： 杂志文章,评审

    doi：10.1007/s10637-011-9758-6

    authors： Cona MM,Wang H,Li J,Feng Y,Chen F,de Witte P,Verbruggen A,Ni Y

    更新日期：2012-10-01 00:00:00

  • Matrix metalloproteinase inhibitors.

    abstract：:The matrix metalloproteinases (MMPs) are a family of at least fifteen secreted and membrane-bound zinc-endopeptidases. Collectively, these enzymes can degrade all of the components of the extracellular matrix, including fibrallar and non-fibrallar collagens, fibronectin, laminin and basement membrane glycoproteins. MM...

    journal_title：Investigational new drugs

    pub_type： 杂志文章,评审

    doi：10.1023/a:1005722729132

    authors： Wojtowicz-Praga SM,Dickson RB,Hawkins MJ

    更新日期：1997-01-01 00:00:00

  • Cyclosporine and alpha-difluoromethylornithine exhibit differential effects on colon and pancreatic cancer in vitro.

    abstract：:alpha-Difluoromethylornithine (DFMO) is a known irreversible inhibitor of ornithine decarboxylase (ODC), the rate-limiting enzyme in polyamine biosynthesis. Cyclosporine (CsA) has been reported to inhibit ODC activity in vitro. In the present study, we compared the effects of DFMO and CsA on growth, survival, and poly...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/BF00175295

    authors： Saydjari R,Townsend CM Jr,Barranco SC,Thompson JC

    更新日期：1987-01-01 00:00:00

  • AN-7, a butyric acid prodrug, sensitizes cutaneous T-cell lymphoma cell lines to doxorubicin via inhibition of DNA double strand breaks repair.

    abstract：:We previously found that the novel histone deacetylase inhibitor (HDACI) butyroyloxymethyl diethylphosphate (AN-7) had greater selectivity against cutaneous T-cell lymphoma (CTCL) than SAHA. AN-7 synergizes with doxorubicin (Dox), an anthracycline antibiotic that induces DNA breaks. This study aimed to elucidate the m...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-017-0500-x

    authors： Moyal L,Goldfeiz N,Gorovitz B,Rephaeli A,Tal E,Tarasenko N,Nudelman A,Ziv Y,Hodak E

    更新日期：2018-02-01 00:00:00

  • Discovery of LY2457546: a multi-targeted anti-angiogenic kinase inhibitor with a novel spectrum of activity and exquisite potency in the acute myelogenous leukemia-Flt-3-internal tandem duplication mutant human tumor xenograft model.

    abstract：:LY2457546 is a potent and orally bioavailable inhibitor of multiple receptor tyrosine kinases involved in angiogenic and tumorigenic signalling. In biochemical and cellular assays, LY2457546 demonstrates potent activity against targets that include VEGFR2 (KDR), PDGFRβ, FLT-3, Tie-2 and members of the Eph family of re...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-011-9640-6

    authors： Burkholder TP,Clayton JR,Rempala ME,Henry JR,Knobeloch JM,Mendel D,McLean JA,Hao Y,Barda DA,Considine EL,Uhlik MT,Chen Y,Ma L,Bloem LJ,Akunda JK,McCann DJ,Sanchez-Felix M,Clawson DK,Lahn MM,Starling JJ

    更新日期：2012-06-01 00:00:00

  • In vitro antitumor effect of recombinant human tumor necrotizing factor on cultured human cancer cell lines and freshly isolated lung cancer cells by the human tumor clonogenic assay.

    abstract：:In vitro antitumor effects of human recombinant tumor necrotizing factor (rH-TNF) were examined against nine lung cancer cell lines including six non small and three small cell lung cancer, four stomach cancer cell lines and 30 freshly isolated lung cancer cell samples by the human tumor clonogenic assay. rH-TNF did n...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/BF00169974

    authors： Sasaki Y,Kanzawa F,Takahashi H,Matsushima Y,Nakano H,Nakagawa K,Hong WS,Minato K,Fujiwara Y,Saijo N

    更新日期：1987-12-01 00:00:00

  • Phase I clinical study of nafazatrom.

    abstract：:Nafazatrom, a synthetic pyrazolinone derivative, has been shown to have substantial antitumor activity in vitro and antitumor and antimetastatic activity in experimental animal systems. The drug has produced no substantial toxicity in preclinical studies and during limited human trials. A phase I clinical trial with t...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/BF00179592

    authors： Hortobagyi GN,Papadoupoulos NE,Frye D,Ajani J,Reuben JM

    更新日期：1986-01-01 00:00:00

  • Synergistic effects of the combination of β-ionone and sorafenib on metastasis of human hepatoma SK-Hep-1 cells.

    abstract：:The combination of anti-cancer drugs with nutritional factors is a potential strategy for improving the efficacy of chemotherapy, particularly for hepatocellular carcinoma because its conventional therapies are mostly ineffective. Using a highly invasive hepatoma SK-Hep-1 cell line, we investigated the possible synerg...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-011-9727-0

    authors： Huang CS,Lyu SC,Hu ML

    更新日期：2012-08-01 00:00:00

  • Targeting specificity protein 1 transcription factor and survivin using tolfenamic acid for inhibiting Ewing sarcoma cell growth.

    abstract：:Transcription factor Specificity protein 1 (Sp1) and its downstream target survivin (inhibitor of apoptosis protein), play major roles in the pathogenesis of various cancers. Ewing Sarcoma (ES) is a common soft tissue/bone tumor in adolescent and young adults. Overexpression of survivin is also linked to the aggressiv...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-016-0417-9

    authors： Shelake S,Sankpal UT,Paul Bowman W,Wise M,Ray A,Basha R

    更新日期：2017-04-01 00:00:00

  • Phase II trial of taxol in patients with adenocarcinoma of the upper gastrointestinal tract (UGIT). The Eastern Cooperative Oncology group (ECOG) results.

    abstract：:Taxol was administered as a 24-hour continuous infusion at 250 mg/m2 in this Phase II trial in patients with adenocarcinomas of the upper gastrointestinal tract (UGIT). Twenty-five patients were entered between July 1991 and June 1992, twenty-three were eligible and were evaluated for toxicity and twenty-two were asse...

    journal_title：Investigational new drugs

    pub_type： 临床试验,杂志文章

    doi：10.1007/BF00873804

    authors： Einzig AI,Lipsitz S,Wiernik PH,Benson AB 3rd

    更新日期：1995-01-01 00:00:00

  • A phase 1b study of the MET inhibitor capmatinib combined with cetuximab in patients with MET-positive colorectal cancer who had progressed following anti-EGFR monoclonal antibody treatment.

    abstract：:Background Overcoming resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) in patients with KRAS wildtype (WT) metastatic colorectal cancer (mCRC) could help meet the needs of patients with limited treatment options. Methods In this phase 1b study, patients with N/KRAS WT, MET-positi...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-020-00928-z

    authors： Delord JP,Argilés G,Fayette J,Wirth L,Kasper S,Siena S,Mesia R,Berardi R,Cervantes A,Dekervel J,Zhao S,Sun Y,Hao HX,Tiedt R,Vicente S,Myers A,Siu LL

    更新日期：2020-12-01 00:00:00

  • Prolonged infusion of gemcitabine in advanced solid tumors: a phase-I-study.

    abstract：BACKGROUND:Gemcitabine is a pro-drug that has to be phosphorylated to gemcitabine-triphosphate in order to exhibit its antineoplastic activity. This reaction involves the enzyme deoxycytidine kinase which is saturated at plasma concentrations following standard 30-min infusions. Pharmacological studies indicate that pr...

    journal_title：Investigational new drugs

    pub_type： 临床试验,杂志文章

    doi：10.1007/s10637-005-5859-4

    authors： Schmid P,Schweigert M,Beinert T,Flath B,Sezer O,Possinger K

    更新日期：2005-03-01 00:00:00

  • Determinants of pain in advanced HCC patients recieving hepatic artery infusion chemotherapy.

    abstract：:Purpose Hepatic arterial infusion chemotherapy (HAIC) is one of the options to treat unresectable hepatocellular carcinoma (HCC). The majority of HCC patients suffer great pain in the course of HAIC treatment. To improve the quality of life and the efficacy of HAIC treatment, the causes of pain, the choice of an analg...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-020-01009-x

    authors： Wu Z,Guo W,Chen S,Zhuang W

    更新日期：2020-10-01 00:00:00

  • Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial.

    abstract：PURPOSE:Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS:Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The pat...

    journal_title：Investigational new drugs

    pub_type： 临床试验,杂志文章,多中心研究

    doi：10.1007/s10637-006-5937-2

    authors： Sawa T,Yana T,Takada M,Sugiura T,Kudoh S,Kamei T,Isobe T,Yamamoto H,Yokota S,Katakami N,Tohda Y,Kawakami A,Nakanishi Y,Ariyoshi Y

    更新日期：2006-03-01 00:00:00

  • First-in-human study of the antibody DR5 agonist DS-8273a in patients with advanced solid tumors.

    abstract：:Background DR5 is a transmembrane receptor that transduces extracellular ligand-binding to activate apoptosis signaling cascades. This phase 1 study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a new monoclonal antibody potent DR5 agonist, DS-8273a, in subjects with advanced solid...

    journal_title：Investigational new drugs

    pub_type： 杂志文章,多中心研究

    doi：10.1007/s10637-016-0420-1

    authors： Forero A,Bendell JC,Kumar P,Janisch L,Rosen M,Wang Q,Copigneaux C,Desai M,Senaldi G,Maitland ML

    更新日期：2017-06-01 00:00:00

  • Aberrant crypt foci and AgNORs as putative biomarkers to evaluate the chemopreventive efficacy of pronyl-lysine in rat colon carcinogenesis.

    abstract：:Chemoprevention opens new perspectives in the prevention of cancer and other degenerative diseases. Use of target-organ biological models at the histological and genetic levels can markedly facilitate the identification of potential chemopreventive agents. Our aim was to study the chemopreventive efficacy of pronyl-ly...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-008-9122-7

    authors： Panneer Selvam J,Aranganathan S,Nalini N

    更新日期：2008-12-01 00:00:00

  • Developmental antiangiogenic agents for the treatment of non-small cell lung cancer (NSCLC).

    abstract：:Standard therapy for advanced or metastatic non-small cell lung cancer (NSCLC) has primarily consisted of traditional cytotoxic chemotherapy, although use of targeted therapies has been approved in specific settings. Antiangiogenic agents represent a promising therapeutic strategy for treatment of advanced NSCLC. Beva...

    journal_title：Investigational new drugs

    pub_type： 杂志文章,评审

    doi：10.1007/s10637-011-9750-1

    authors： Blumenschein GR Jr

    更新日期：2012-08-01 00:00:00

  • Chemosensitivity of various peritoneal cancer cell lines to HIPEC and PIPAC: comparison of an experimental duplex drug to standard drug regimens in vitro.

    abstract：:We performed an in-vitro study testing the chemosensitivity of peritoneal cancer cell lines (SW620, HCT116, MKN45, 23,132/87, OAW42) to various cytostatic drug regimens. A duplex drug, characterized by reversible linking of the antimetabolites 2'-deoxy-5-fluorouridine (5-FdU) and 3'-C-ethynylcytidine (ECyd), was compa...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-018-0641-6

    authors： Weinreich J,Struller F,Sautkin I,Giuashvili S,Reymond M,Königsrainer A,Schott TC

    更新日期：2019-06-01 00:00:00

  • Cytotoxicity of withaferin A in glioblastomas involves induction of an oxidative stress-mediated heat shock response while altering Akt/mTOR and MAPK signaling pathways.

    abstract：:Withaferin A (WA), a steroidal lactone derived from the plant Vassobia breviflora, has been reported to have anti-proliferative, pro-apoptotic, and anti-angiogenic properties against cancer growth. In this study, we identified several key underlying mechanisms of anticancer action of WA in glioblastoma cells. WA was f...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-012-9888-5

    authors： Grogan PT,Sleder KD,Samadi AK,Zhang H,Timmermann BN,Cohen MS

    更新日期：2013-06-01 00:00:00

  • Dual modulation of JNK and Akt signaling pathways by chaetoglobosin K in human lung carcinoma and ras-transformed epithelial cells.

    abstract：:Chaetoglobosin K (ChK) is a natural product that inhibits anchorage-dependent and anchorage-independent growth of ras-transformed cells, prevents tumor-promoter disruption of cell-cell communication, and reduces Akt activation in tumorigenic cells. This study demonstrates how ChK modulates the JNK pathway in ras-trans...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-012-9883-x

    authors： Ali A,Sidorova TS,Matesic DF

    更新日期：2013-06-01 00:00:00

  • Using the neurotransmitter serotonin to target imaging agents to glioblastoma cells.

    abstract：:The neurotransmitter serotonin is involved in numerous bodily functions via seven different serotonin receptor subfamilies. Serotonin plays a role in gastrointestinal functions like intestinal secretion or peristalsis and neuropsychiatric events like depression or migraine. One of these subtypes has been found on glio...

    journal_title：Investigational new drugs

    pub_type： 杂志文章

    doi：10.1007/s10637-011-9781-7

    authors： Sturzu A,Sheikh S,Klose U,Echner H,Kalbacher H,Deeg M,Nägele T,Horger M,Ernemann U,Heckl S

    更新日期：2012-12-01 00:00:00

  • A first-in-human phase I trial of LY2780301, a dual p70 S6 kinase and Akt Inhibitor, in patients with advanced or metastatic cancer.

    abstract：:The primary objective of this phase I study of LY2780301, a dual p70 S6 kinase and Akt inhibitor, was to determine the recommended phase II dose as a single agent in patients with advanced cancer. Secondary objectives included safety, pharmacokinetic, and pharmacodynamic analyses, and co-clinical analyses in Avatar mo...

    journal_title：Investigational new drugs

    pub_type： 杂志文章,多中心研究

    doi：10.1007/s10637-015-0241-7

    authors： Azaro A,Rodon J,Calles A,Braña I,Hidalgo M,Lopez-Casas PP,Munoz M,Westwood P,Miller J,Moser BA,Ohnmacht U,Bumgardner W,Benhadji KA,Calvo E

    更新日期：2015-06-01 00:00:00