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New Drugs Online Report for moxetumomab
Information
Generic Name:
moxetumomab 
Trade Name:  
Synonym: CAT-8015 
Entry Type: New molecular entity  
 
Developmental Status
UK: Phase I Clinical Trials. 
EU: Phase I Clinical Trials. 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
Dec 13: EU & US filings now expected to be 2018 [3]. 
03/03/2014 17:43:04
Jun 13: EU & US filings planned for 2017 [2]. 
02/09/2013 12:17:30
Apr 13: PIII study started Mar 13 [1]. 
30/04/2013 11:53:33
 
Trial or other data
NCT01829711 is a PIII open-label, multicentre trial of moxetumomab pasudotox in 80 subjects with relapsed/ refractory hairy cell leukaemia. Patients must have had at least 2 prior systemic therapies, including at least 2 prior courses of purine analogue, or 1 if the response to this course lasted <1 year, or if the patient had unacceptable toxicity to purine analogue. Moxetumomab (40mcg/kg) will be given over 30 minutes on days 1, 3 and 5 of a 28 day cycle. The study will focus on the results from the first 6 months of treatment, although participants will continue to take the study drug for as long as it is effective and the side effects are not severe. The primary outcome is rate of complete response. The US National Cancer Institute is collaborating in this study. The study starts Mar 13 and is due to complete Dec 14 [1]. 
30/04/2013 11:53:46
   
References  
Available only to registered users
Category
BNF Category:
Other antineoplastic drugs (08.01.05)
Pharmacology: anti-CD22 drug  
Epidemiology:  
Indication: Hairy cell leukaemia 
 
Method(s) of Administration
Intravenous infusion 
 
Company Information
Name: MedImmune 
US Name: MedImmune 
 
NICE Information
Anticipated Commissioning route (England)
In timetable: -