Moxetumomab pasudotox

Unassigned

New Medicines

Lumoxiti · Hairy cell leukaemia, treatment refractory (stage III or IV) in adults - after two previous treatments with purine analogues have failed

Information

Lumoxiti
New molecular entity
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Yes

Q4 18: EU filing based on PLAIT planned for 2020 [16].


Q4 18: Has been launched in the US [14].


Sep 18: AstraZeneca plans to submit MAA to the EMA in 2018 [15].


Sep 18: Approved in US [11]


Apr 18: granted priority review in US [10]


Jan 18: Estimated US filing date H1 2018; no proposed date for EU filing given [9].


Feb 16: US planned filing bought forward to 2017 [7].


Feb 15: Plans for filing unchanged [6].


Dec 13: EU & US filings now expected to be 2018 [3].


Jun 13: EU & US filings planned for 2017 [2].


Apr 13: PIII study started Mar 13 [1].

Category

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.
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.
Hairy cell leukaemia, treatment refractory (stage III or IV) in adults - after two previous treatments with purine analogues have failed
Intravenous infusion

Further information

Yes
Suspended

Trial or other data

Jul 18: Results of PIII trial NCT01829711 published in Leukemia journal [13]


Dec 17: PIII PLAIT trial (NCT01829711) meets its primary endpoint [8].


Jan 17: NCT01829711 Estimated Primary Completion Date: April 2017


Aug 14: PIII NCT01829711 is currently recruiting pts. Collection of primary outcome data is now expected to complete in Sep 16 [5].


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].

Evidence based evaluations