Drugs / Mogamulizumab
Mogamulizumab
also known as
KW-0761 · AMG 761 · KM-8761 · Mogamulizumab (genetical recombination) · Mogamulizumab-Kpkc · Mogamulizumab: KW-0761 · Poteligeo
Monoclonal antibody targets CCR4
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed adult T-cell leukemia/lymphoma 3 milestones | |||||
| Filed | Japan (PMDA) | POTELIGEO® Injection 20 mg | adult T-cell leukemia/lymphoma | 2014-06-30 | “re-filed an application to Japan's Ministry of Health, Labour and Welfare ("MHLW") seeking approval for additional indication for untreated CCR4-positive adult T-cell...” kyowakirin.com ↗ |
| Filed | Japan (PMDA) | POTELIGEO® | adult T-cell leukemia/lymphoma | 2013-07-19 | “filed an application to Japan's Ministry of Health, Labour and Welfare ("MHLW") seeking approval for additional indication for untreated CCR4-positive adult T-cell...” kyowakirin.com ↗ |
| Filed | Japan (PMDA) | — | adult T-cell leukemia/lymphoma | 2011-04-26 | “has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761” kyowakirin.com ↗ |
| Filed primary cutaneous T-cell lymphoma 2 milestones | |||||
| Filed | US (FDA) | — | primary cutaneous T-cell lymphoma | 2017-11-28 | “FDA has accepted for review the Biologics License Application (BLA) for mogamulizumab to treat Cutaneous T-cell Lymphoma (CTCL)” kyowakirin.com ↗ |
| Filed | EU (EMA) | — | primary cutaneous T-cell lymphoma | 2017-10-27 | “has been validated by the European Medicines Agency (EMA) and is now under review.” kyowakirin.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Poteligeo | — | 2018-11-22 | europa.eu ↗ |
| Approved | US (FDA) | POTELIGEO | — | 2018-08-08 | fda.gov ↗ |
Trials 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06235281 | Jan 2024 → Sep 2026 | mycosis fungoides | H. Lee Moffitt Cancer Center and Research Institute | Suspended | No outcome recorded Stop: Enrollment |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT05414500 | May 2023 → Jun 2027 | mycosis fungoides | University of Alabama at Birmingham | Suspended | No outcome recorded |
| Phase 1 | NCT04848064 | May 2022 → Oct 2026 expected | adult T-cell leukemia/lymphoma, primary cutaneous T-cell lymphoma | John Reneau | Recruiting | No outcome recorded |
| Phase 1 | NCT04185220 | Feb → Nov 2020 | Sezary syndrome, adult T-cell leukemia/lymphoma, mycosis fungoides | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02867007 | Aug 2016 → Dec 2019 | carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02946671 | Mar 2016 → Mar 2020 | esophageal cancer, gastric cancer, kidney cancer, lung cancer +1 | Osaka University | Completed | No outcome recorded |
| Phase 1 | NCT02476123 | Jun 2015 → Feb 2018 | cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02444793 | May 2015 → Sep 2017 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT02358473 | Jan 2015 → Dec 2016 | non-small cell lung carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02301130 | Nov 2014 → Dec 2017 | cancer | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 1 | NCT01929486 | Feb 2013 → Jun 2016 | cancer | Aichi Medical University | Unknown | No outcome recorded |
| Phase 1 | NCT01514981 | Dec 2011 → Jan 2014 | asthma | Amgen | Terminated | No outcome recorded |
| Phase 1 | NCT00355472 | Feb 2007 → Oct 2008 | adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma, not otherwise specified | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT04676087 | Apr 2021 → Oct 2023 | Sezary syndrome, mycosis fungoides | Emory University | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04541017 | Apr 2021 → Oct 2024 | Sezary syndrome, mycosis fungoides | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT03309878 | Oct 2018 → Jan 2021 | high grade B-cell lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT02705105 | Feb 2016 → Aug 2018 | hepatocellular carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02281409 | Oct 2014 → Feb 2020 | cancer, metastatic neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00888927 | May 2009 → Sep 2012 | peripheral T-cell lymphoma, not otherwise specified | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 213 trials · 1 met primary | ||||||
| Phase 2 | NCT06698003 | Nov 2024 → Nov 2029 expected | T-cell and NK-cell neoplasm, adult T-cell leukemia/lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05996185 | Oct 2024 → Nov 2026 expected | T-cell non-Hodgkin lymphoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05956041 | Dec 2023 → Dec 2026 expected | mycosis fungoides and variants | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04128072 | Mar 2023 → Oct 2026 expected | primary cutaneous T-cell lymphoma | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 2 | NCT04930653 | Oct 2022 → Jun 2028 expected | Sezary syndrome, folliculotropic mycosis fungoides | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04745234 | Aug 2021 → May 2025 | primary cutaneous T-cell lymphoma | Kyowa Kirin, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04256018 | Mar 2020 → Dec 2026 expected | Sezary syndrome, mycosis fungoides | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT01626664 | Jun 2012 → Aug 2015 | adult T-cell leukemia/lymphoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01611142 | Apr 2012 → May 2015 | peripheral T-cell lymphoma, not otherwise specified | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01192984 | Sep 2010 → May 2012 | mature T-cell and NK-cell non-Hodgkin lymphoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01226472 | Aug 2010 → Sep 2012 | peripheral T-cell lymphoma, not otherwise specified, primary cutaneous T-cell lymphoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01173887 | Jul 2010 → Apr 2012 | adult T-cell leukemia/lymphoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00920790 | Jun 2009 → Jul 2010 | adult T-cell leukemia/lymphoma | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT03191526 | May 2017 → Jun 2019 | tropical spastic paraparesis | Kyowa Kirin, Inc. | Terminated | Missed primary |
| Phase 3 | NCT01728805 | Nov 2012 → Mar 2017 | primary cutaneous T-cell lymphoma | Kyowa Kirin, Inc. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06285370 | May 2023 → Aug 2025 | primary cutaneous T-cell lymphoma | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07529405 Comparator | Jul 2026 → Dec 2030 expected | mycosis fungoides | Virogen Biotechnology Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2020-01-31 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Final Safety Data of POTELIGEO® (mogamulizumab-kpkc) from MAVORIC Trial kyowakirin.com ↗
Kyowa Kirin, Inc., (Kyowa Kirin, TSE: 4151) announces the final safety data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) trial of POTELIGEO® (mogamulizumab-kpkc), which will be presented today at the 12th Annual T-Cell Lymphoma Forum (TCLF) in La Jolla, California. |
| 2018-11-26 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces POTELIGEO® Receives Marketing Authorisation in Europe for the Treatment of Mycosis Fungoides and Sézary SyndromePOTELIGEO will be the first biologic agent targeting CCR4 to be available for patients in Europe. kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that it has received a European Commission decision granting a marketing authorisation to POTELIGEO® (Generic name: mogamulizumab), a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. |
| 2018-09-21 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces Mogamulizumab Received Positive CHMP Opinion for the Treatment of Mycosis Fungoides and Sézary SyndromeIf approved, mogamulizumab would be the first biologic agent targeting CCR4 to be available for patients in Europe. kyowakirin.com ↗ |
| 2018-08-21 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Receives the Partial Change Approval of POTELIGEO® in Japan kyowakirin.com ↗
Tokyo, Japan, August 21, 2018 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and COO: Masashi Miyamoto; "Kyowa Hakko Kirin") today announces that it has obtained the partial change approval for POTELIGEO®* (code name: KW-0761; generic name: mogamulizumab) from the Ministry of Health, Labor and Welfare in Japan. |
| 2018-08-09 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome kyowakirin.com ↗
Poteligeo has been approved for the treatment of the two most common types of Cutaneous T-cell lymphoma (CTCL) in previously treated patients based on data showing improved progression-free survival (PFS) and overall response rate (ORR) when compared to vorinostat. |
| 2018-05-30 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab kyowakirin.com ↗
In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) target action date has been extended to September 4, 2018. |
| 2017-12-11 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results of Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma at the American Society of Hematology 2017 kyowakirin.com ↗
In the study, the patients who received mogamulizumab had significantly better PFS compared to vorinostat with a median PFS of 7.7 months for mogamulizumab and 3.1 months for vorinostat (p<0.0001). |
| 2017-11-30 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits the Partial Change Approval Application of Mogamulizumab in Japan kyowakirin.com ↗
"We are happy to file the application of mogamulizumab in CTCL in Japan," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. |
| 2017-11-28 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Announces FDA Acceptance for Filing and Priority Review Designation of Mogamulizumab's Biologics License Application kyowakirin.com ↗
The FDA has granted mogamulizumab Priority Review status, which is available to drugs that would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. |
| 2017-10-27 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Announces Marketing Authorisation Application for Mogamulizumab Validated by European Medicines Agency kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announces that its marketing authorisation application (MAA) for mogamulizumab, for the treatment of cutaneous T-cell lymphoma (CTCL) in adults who have received at least one prior systemic therapy, has been validated by the European Medicines Agency (EMA) and is now under review. |
| 2017-08-25 | Kyowa Kirin, Inc. | Regulatory US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the treatment of Mycosis Fungoides and Sézary Syndrome kyowakirin.com ↗
Breakthrough Therapy Designation was granted based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study. |
| 2017-04-07 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Positive Results of the Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma kyowakirin.com ↗
The top-line results demonstrated a statistically significant improvement in progression free survival in the mogamulizumab arm compared to the control (vorinostat) arm, and tolerable safety profile of mogamulizumab. |
| 2016-06-06 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Preliminary Results from Pivotal Phase 2 Study of Mogamulizumab (KW-0761) in Patients with Relapsed or Refractory Adult T-cell Leukemia-Lymphoma kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced the preliminary results today from the pivotal Phase 2 study of mogamulizumab (Code name: KW-0761) for the treatment of Adult T-cell Leukemia-Lymphoma (ATL). |
| 2014-12-18 | Kyowa Kirin, Inc. | Regulatory Approval for Additional Indication for Chemotherapy-Native CCR4-positive ATL of Mogamulizumab kyowakirin.com ↗
Kyowa Hakko Kirin Co, Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced that it has received approval for additional indication for chemotherapy-native CCR4-positive adult T-cell leukemia-lymphoma (ATL) of Mogamulizumab (brand name: POTELIGEO® Injection 20 mg) from Japan's Ministry of Health, Labour and Welfare ("MHLW"). |
| 2014-06-30 | Kyowa Kirin, Inc. | Regulatory Reapplication Seeking Approval for Additional Indication for ATL of Mogamulizumab kyowakirin.com ↗
Recently, through consultation with the regulatory agency, additional information for review will be available, Kyowa Hakko Kirin has decided to re-file an application. |
| 2014-03-17 | Kyowa Kirin, Inc. | Regulatory Approval for Additional Indication for PTCL and CTCL of Mogamulizumab kyowakirin.com ↗
it has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab |
| 2014-02-10 | Kyowa Kirin, Inc. | Regulatory Change to Supplemental Application Seeking Approval of Additional Indication for Mogamulizumab kyowakirin.com ↗
Company plans to re-file the application for untreated CCR4-positive ATL when additional required information is available. |
| 2013-07-19 | Kyowa Kirin, Inc. | Regulatory Application Seeking Approval for Additional Indication for ATL, PTCL and CTCL of Mogamulizumab kyowakirin.com ↗ |
| 2012-12-11 | Kyowa Kirin, Inc. | Results Results of a Phase 2 Clinical Trial on Mogamulizumab (KW-0761) to Treat Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL) in Japan kyowakirin.com ↗
The study's primary endpoint for efficacy was overall response rate (ORR) and the results showed an ORR of 35% (95% CI; 20-53%), confirming that mogamulizumab is effective against CCR4-positive relapsed PTCL and CTCL. |
| 2012-03-30 | Kyowa Kirin, Inc. | Regulatory New Drug Application Approval for POTELIGEO® (Mogamulizumab) Injection in Japan, a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL) kyowakirin.com ↗
This product is the first antibody for which Kyowa Hakko Kirin has an NDA approved, and is also the world's first POTELLIGENT® antibody approved for marketing approval. |
| 2012-03-30 | Kyowa Kirin, Inc. | Regulatory Kyowa Medex Receives Approval for POTELIGEO® TEST IHC and POTELIGEO® TEST FCM, Companion Diagnostics of POTELIGEO® Injection in Japan kyowakirin.com ↗
POTELIGEO® is a therapeutic antibody for which Kyowa Hakko Kirin has a new drug application (NDA) approved today from the MHLW. |
| 2011-04-26 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin submitted New Drug Application in Japan for KW-0761, a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL) kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761 under development for the treatment of adult T-cell leukemia-lymphoma (ATL). |
| 2011-04-26 | Kyowa Kirin, Inc. | Regulatory Kyowa Medex Submitted New Drug Application for In Vitro Diagnostic Reagent to Detect CCR4 Proteins in Japan kyowakirin.com ↗
These products are used for aiding the diagnosis for therapy of adult T-cell leukemia-lymphoma (ATL), a target disease for KW-0761 whose new drug application (NDA) was submitted today by Kyowa Hakko Kirin Co., Ltd. |
| 2010-12-08 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results from US Phase 1/2 Clinical Trial of KW-0761 (Anti-CCR4 Humanized Monoclonal Antibody) in Patients with Cutaneous T-cell lymphoma kyowakirin.com ↗
The overall response rate was 42% (SS: 50%, MF: 36%),including 3 complete responses. |
| 2010-12-07 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Results from Japan Phase 2 Clinical Trial of KW-0761 (Anti-CCR4 Humanized Monoclonal Antibody) in Patients with Recurrent or Relapsed Adult T-Cell Leukemia-Lymphoma (ATL) kyowakirin.com ↗
As for the efficacy, the overall response rate as the primary endpoint was 50% (95% CI; 30 – 70%), which validated the efficacy of KW-0761 against recurrent or relapsed CCR4-positive ATL. |
All press releases naming this drug 38 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mogamulizumab | “Mogamulizumab (KW-0761) is a defucosylated humanized anti-CCR4 antibody engineered to exert potent antibody-dependent cellular cytotoxicity.” PMID 24616310 ↗ Mar 201424“Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma.” PMID 25605368 ↗ Jan 2015 |
| Known as | AMG 761 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01514981 ↗ |
| Known as | KM-8761 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743041 ↗ |
| Known as | KW-0761 | “Mogamulizumab (KW-0761) is a defucosylated humanized anti-CCR4 antibody engineered to exert potent antibody-dependent cellular cytotoxicity.” PMID 24616310 ↗ Mar 2014 |
| Known as | Mogamulizumab (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743041 ↗ |
| Known as | Mogamulizumab-Kpkc | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06235281 ↗ |
| Known as | Mogamulizumab: KW-0761 | “Mogamulizumab: KW-0761” NCT02867007 ↗ |
| Known as | Poteligeo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743041 ↗ |
| Action | Deplete | “with enhanced antibody dependent cellular cytotoxicity (ADCC)” NCT01611142 ↗ |
| Modality | Monoclonal antibody | “a defucosylated, humanized, anti-CC chemokine receptor 4 monoclonal antibody” PMID 25605368 ↗ Jan 2015 |
| Route | Intravenous | “IV administration at 4 escalating dose levels.” NCT00355472 ↗ |
| Target | CCR4 | “anti-CCR4 antibody” PMID 25605368 ↗ Jan 2015 |