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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
Innate Pharma
Innate Pharma and AstraZeneca

Development and Regulatory status

Licence withdrawn
Licence withdrawn
Launched
Yes
Yes
Jul 21European Commission withdraws the marketing authorisation for Lumoxiti (moxetumomab pasudotox) in the EU at the request of AstraZeneca AB, after its decision to permanently discontinue the marketing of the product for commercial reasons. The product had not been marketed in the EU [21].
Feb 21Approved in the EU [21].
Dec 20Recommended for EU approval under exceptional circumstances by CHMP - the full indication is "for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (PNA)". Authorisation under exceptional circumstances allows a licence to be granted when the full data normally required cannot be collected. The licence is renewed annually and there will normally be a requirement to collect further data on safety and efficacy, but there is no set limit on renewals [20].
Jun 20Has orphan drug status in EU for treatment of hairy cell leukaemia [19].
Jan 20 The EMA has accepted the MAA for moxetumomab pasudotox-tdfk indicated for adult patients with relapsed or refractory hairy cell leukemia [18].
Nov 19In its latest quarterly report, Innate states that the submission to file for EU approval of Lumoxiti for treatment of patients with R/R HCL by AstraZeneca is on track and expected by end of 2019. Upon the submission, AstraZeneca is eligible to receive a regulatory milestone of $15 million [17].
Dec 18EU filing based on PLAIT planned for 2020 [16].
Dec 18Has been launched in the US [14].
Oct 18Innate Pharma enters into an agreement with AstraZeneca for its FDA approved moxetumomab pasudotox. Under the terms of agreement, Innate is licensing the commercial rights of moxetumomab pasudotox in the US (and will co-commericalise in the US) and will be responsible for the development, regulatory submission, approval and and commercialisation of the drug in the EU [17].
Sep 18AstraZeneca plans to submit MAA to the EMA in 2018 [15].
Sep 18Approved in US [11]
Apr 18Granted priority review in US [10]
Jan 18Estimated US filing date H1 2018; no proposed date for EU filing given [9].
Feb 16US planned filing bought forward to 2017 [7].
Feb 15Plans for filing unchanged [6].
Dec 13EU & US filings now expected to be 2018 [3].
Jun 13EU & US filings planned for 2017 [2].
Apr 13PIII 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

Trial or other data

Jul 18Results of PIII trial NCT01829711 published in Leukemia journal [13]
Dec 17PIII PLAIT trial (NCT01829711) meets its primary endpoint [8].
Jan 17NCT01829711 Estimated Primary Completion Date: April 2017
Aug 14PIII NCT01829711 is currently recruiting pts. Collection of primary outcome data is now expected to complete in Sep 16 [5].
Apr 13NCT01829711 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