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New Drugs Online Report for moxetumomab pasudotox
Generic Name:
moxetumomab pasudotox 
Trade Name:  
Synonym: CAT-8015;GCR-8015; HA22 
Entry Type: New molecular entity  
Development and Regulatory 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:  
Feb 16: US planned filing bought forward to 2017 [7]. 
24/03/2016 11:21:59
Feb 15: Plans for filing unchanged [6]. 
03/03/2015 14:13:22
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
Aug 14: PIII NCT01829711 is currently recruiting pts. Collection of primary outcome data is now expected to complete in Sep 16 [5]. 
03/03/2015 14:10:04
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
Available only to registered users
BNF Category:
Other antineoplastic drugs (08.01.05)
Pharmacology: An anti-CD22 mouse monoclonal antibody consisting of a disulphide-linked FV antibody fragment, which targets the CD22 receptor, fused with an engineered toxin that minimises non-targeted toxicity.  
Epidemiology: HCL is a rare type of chronic leukaemia, accounting for approximately 2% of all leukaemia cases [4]. Approximately 200 people in the UK are diagnosed with HCL each year.  
Indication: Hairy cell leukaemia 
Additional Details: treatment refractory (stage III or IV) in adults - after two previous treatments with purine analogues have failed 
Method(s) of Administration
Intravenous infusion 
Company Information
Name: AstraZeneca 
US Name: MedImmune 
Further Information
Anticipated commissioning route (England) NHSE 
High cost drug list? Awaiting Update
Implications Available only to registered users