Mogamulizumab

Kyowa Kirin welcomes the decision that NICE will revisit their appraisal of the innovative systemic treatment, POTELIGEO®▼ (mogamulizumab), for adults living with two forms of ultra-rare non-Hodgkin lymphoma

Friday, June 11, 2021 - 1:51pm

Kyowa Kirin remains committed to finding a solution for people living with SS or MF to have access to POTELIGEO and will continue discussions with NICE and NHS England to find a resolution.

Key Points: 
  • Kyowa Kirin remains committed to finding a solution for people living with SS or MF to have access to POTELIGEO and will continue discussions with NICE and NHS England to find a resolution.
  • We strongly believe in the clinical and cost effectiveness of POTELIGEO and will continue a dialogue with NICE and NHS England.
  • We are hopeful that NICEs reassessment might bring parity with the SMCs decision to make mogamulizumab available in Scotland.
  • You can learn more about the business of Kyowa Kirin at:

Kyowa Kirin: New Data Analysis Shows Link between Blood Involvement and Response to Treatment in Cutaneous T-cell Lymphoma (CTCL) Patients

Thursday, June 10, 2021 - 10:00am

We know that increasing levels of malignant T-cells in the blood correlate with increased risk of CTCL disease progression and an overall reduction in patient survival.

Key Points: 
  • We know that increasing levels of malignant T-cells in the blood correlate with increased risk of CTCL disease progression and an overall reduction in patient survival.
  • Treatment with mogamulizumab has also been shown to be more effective in CTCL patients who have blood involvement as part of their disease and treatment with mogamulizumab also generates quality of life benefits for CTCL patients with blood involvement.
  • This new information underlines the importance of blood monitoring in the clinical management of CTCL patients.
  • Statistically significant differences in quality of life were seen for patients with blood involvement, with patients treated with mogamulizumab seeing improvements in the Skindex-29 and ItchyQoL questionnaires, compared to vorinostat.

The Scottish Medicines Consortium (SMC) Accepts Kyowa Kirin’s POTELIGEO® (mogamulizumab) for the Treatment of Those Living With Certain Ultra-rare Blood Cancers

Monday, June 7, 2021 - 2:54pm

Ropinder Gill, Chief Executive at Lymphoma Action commented: This is a hugely significant development for those living in Scotland with these rare haematological cancers.

Key Points: 
  • Ropinder Gill, Chief Executive at Lymphoma Action commented: This is a hugely significant development for those living in Scotland with these rare haematological cancers.
  • Mogamulizumab offers people with MF and SS a much-needed new treatment option for a disease where, to date, therapies have been limited.
  • Advice on new medicines mogamulizumab 4mg/mL concentrate for solution with infusion (POTELIGEO).
  • British Association of Dermatologists and UK Cutaneous Lymphoma Group Guidelines for the management of primary cutaneous lymphoma.

Kyowa Kirin Presents New Data on Response to Treatment in Cutaneous T-cell Lymphoma (CTCL) Patients Who Have Blood Involvement

Tuesday, October 13, 2020 - 11:00am

Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced data from a post hoc analysis of the MAVORIC trial.

Key Points: 
  • Kyowa Kirin International PLC (Kyowa Kirin), a wholly owned subsidiary of Kyowa Kirin Co., Ltd., today announced data from a post hoc analysis of the MAVORIC trial.
  • Assessment of blood involvement is part of this staging process.
  • The data highlights that mogamulizumab is more effective in MF and SS patients who have blood involvement as part of their disease.
  • MF and SS are subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin's lymphoma that can affect the skin, blood, lymph nodes and internal organs.2 CTCL is rare.

Kyowa Kirin Presents Post-Hoc Analysis of Pivotal Trial for Poteligeo® (mogamulizumab-kpkc)

Monday, June 3, 2019 - 2:00pm

Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Key Points: 
  • Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
  • Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO.
  • You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies.

Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome

Wednesday, August 8, 2018 - 5:16pm

TOKYO, Aug. 8, 2018 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Szary syndrome (SS) after at least one prior systemic therapy.

Key Points: 
  • TOKYO, Aug. 8, 2018 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Szary syndrome (SS) after at least one prior systemic therapy.
  • "Mycosis fungoides (MF) and Szary syndrome (SS) can be disfiguring, and debilitating.
  • You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • POTELIGEO was produced using Kyowa Hakko Kirin's proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC).

Kyowa Kirin Presents New Data for Mogamulizumab from Its Lead Program in Cutaneous T-cell Lymphoma (CTCL) at ASCO

Monday, June 4, 2018 - 2:00pm

MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL).

Key Points: 
  • MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
  • Infusion reaction and rash were the most common adverse events associated with mogamulizumab.
  • Mogamulizumab was produced using Kyowa Hakko Kirin's proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity.
  • The study was conducted in the U.S., Europe, Japan and Australia, and randomized 372 patients to receive either mogamulizumab or vorinostat.