Drugs / Moxetumomab Pasudotox
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hairy cell leukemia 1 milestone | |||||
| Filed | US (FDA) | — | hairy cell leukemia | 2018-04-03 | “today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox” astrazeneca.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Lumoxiti | — | 2021-02-08 | europa.eu ↗ |
| Approved | US (FDA) | LUMOXITI | — | 2018-09-13 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT03805932 | Oct 2019 → Jul 2023 overdue | hairy cell leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01891981 | Dec 2013 → Apr 2017 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT00659425 | Sep 2008 → Dec 2014 | acute lymphoblastic leukemia | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00515892 | Aug 2007 → ? | leukemia, non-Hodgkin lymphoma | Cambridge Antibody Technology | Unknown | No outcome recorded |
| Phase 1 | NCT00586924 | May 2007 → May 2015 | hairy cell leukemia | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT00462189 | Apr 2007 → ? | hairy cell leukemia | Cambridge Antibody Technology | Unknown | No outcome recorded |
| Phase 1 | NCT00587457 | Mar 2007 → Apr 2008 | chronic lymphocytic leukemia/small lymphocytic lymphoma, prolymphocytic leukemia | MedImmune LLC | Terminated | No outcome recorded |
| Phase 1 | NCT00457860 | Mar 2007 → ? | leukemia | Cambridge Antibody Technology | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01030536 | Feb 2010 → Mar 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02338050 | May 2015 → May 2020 | acute lymphoblastic leukemia | Center for International Blood and Marrow Transplant Research | Terminated | No outcome recorded |
| Phase 2 | NCT02227108 | Aug 2014 → Nov 2015 | B-cell childhood acute lymphoblastic leukemia | MedImmune LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01829711 | Apr 2013 → May 2017 | hairy cell leukemia | MedImmune LLC | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT03501615 | — | hairy cell leukemia | AstraZeneca | Approved for marketing | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00587015 Comparator | Aug 2007 → Mar 2008 | lymphoma | MedImmune LLC | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2018-09-14 | AstraZeneca | Regulatory US FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for certain patients with relapsed or refractory hairy cell leukaemia astrazeneca.com ↗
AstraZeneca and MedImmune, its global biologics research and development arm, announced today that the US Food and Drug Administration (FDA) has approved Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. |
| 2018-06-04 | AstraZeneca | Results Moxetumomab pasudotox pivotal data in patients with previously-treated hairy cell leukaemia presented at the 2018 ASCO Annual Meeting astrazeneca.com ↗
Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response (OR) rate, a 41% complete response (CR) rate, and a 30% durable CR rate (primary endpoint). |
| 2018-04-03 | AstraZeneca | Regulatory US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia astrazeneca.com ↗
The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018. |
All press releases naming this drug 7 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | moxetumomab pasudotox | “Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until...” NCT00587457 ↗8“Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.” NCT01030536 ↗ |
| Known as | CAT-8015 | “Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until...” NCT00587457 ↗7“Participants received intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) without concomitant corticosteroid administration every other day (QoD) in a 21-day...” NCT00659425 ↗ “Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.” NCT01030536 ↗ “Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia.” PMID 22355053 ↗ Feb 2012 |
| Known as | HA22 | “Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia.” PMID 22355053 ↗ Feb 2012 |
| Known as | Lumoxiti | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743043 ↗ |
| Known as | Moxe | “Moxetumomab pasudotox (Moxe) is a chimeric protein composed of an anti-CD22 Fv fused to a portion of Pseudomonas exotoxin A” PMID 29432154 ↗ Feb 2018 |
| Known as | Moxetumomab Pasudotox-tdfk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03805932 ↗ |
| Action | Deplete | “The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells.” NCT00462189 ↗ |
| Action | Inhibit | “Elongation factor 2 inhibitor” CHEMBL1743043 ↗ |
| Modality | Protein / enzyme biologic | “escalating doses of recombinant CAT-8015” NCT00457860 ↗ |
| Route | Intravenous | “Patients receive CAT-8015 IV over 30 minutes” NCT00457860 ↗ |
| Target | CD22 | “anti-CD22 recombinant immunotoxin” PMID 22355053 ↗ Feb 2012 |
| Target | EEF2 | “Elongation factor 2 inhibitor” CHEMBL1743043 ↗ |