(Q38042401)

27 August 2017

title

Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin (English)

1 reference

27 August 2017

0 references

2

Masaharu Tsubokura

1 reference

27 August 2017

Tetsuya Tanimoto

1

1 reference

27 August 2017

Jinichi Mori

3

1 reference

27 August 2017

Monika Pietrek

4

1 reference

27 August 2017

Shunsuke Ono

5

1 reference

27 August 2017

Masahiro Kami

6

1 reference

27 August 2017

publication date

11 September 2012

1 reference

Investigational New Drugs

27 August 2017

published in

1 reference

27 August 2017

volume

31

1 reference

27 August 2017

issue

2

1 reference

27 August 2017

page(s)

473-478

1 reference

https://scigraph.springernature.com/pub.10.1007/s10637-012-9877-8

27 August 2017

exact match

0 references

cites work

FDA Increases Focus on Postmarketing Studies

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Cancer clinical trials--a chronic but curable crisis

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Future of Japan's system of good health at low cost with equity: beyond universal coverage

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Acute myeloid leukemia stem cells and CD33-targeted immunotherapy

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial.

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Phase I/II study of humanized anti-CD33 antibody conjugated with calicheamicin, gemtuzumab ozogamicin, in relapsed or refractory acute myeloid leukemia: final results of Japanese multicenter cooperative study

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Gemtuzumab ozogamicin (Mylotarg) as a single agent for molecularly relapsed acute promyelocytic leukemia

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Long-term disease-free survival after gemtuzumab, intermediate-dose cytarabine, and mitoxantrone in patients with CD33(+) primary resistant or relapsed acute myeloid leukemia.

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Cytarabine dose for acute myeloid leukemia

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

A feasibility study of simultaneous administration of gemtuzumab ozogamicin with intensive chemotherapy in induction and consolidation in younger patients with acute myeloid leukemia

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Gemtuzumab ozogamicin as postremission treatment in AML at 60 years of age or more: results of a multicenter phase 3 study

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin

21 January 2018

1 reference

https://api.crossref.org/works/10.1007%2FS10637-012-9877-8

Induction therapy of AML with ara-C plus daunorubicin versus ara-C plus gemtuzumab ozogamicin: a randomized phase II trial in elderly patients

21 January 2018

1 reference

12 December 2020

Gemtuzumab ozogamicin: is there room for salvage?

1 reference

12 December 2020

Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Grup

1 reference

12 December 2020

Sustained molecular remission after low dose gemtuzumab-ozogamicin in elderly patients with advanced acute promyelocytic leukemia

1 reference

12 December 2020

Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups.

1 reference

12 December 2020

Review of Novel Therapeutics by Three Regulatory Agencies

1 reference

12 December 2020

10.1007/S10637-012-9877-8

Identifiers

DOI

1 reference

Dimensions Publication ID

27 August 2017

1032420952

0 references

1 reference