In the MAVORIC phase 3 clinical trial…

POTELIGEO demonstrated a higher overall response rate that lasted longer

More than 5x as many POTELIGEO patients responded1

Bar chart: overall response rate for Poteligeo versus vorinostat
  • POTELIGEO demonstrated a 28% ORR compared with 5% in vorinostat-treated patients
  • ORR was based on a global composite response score of all disease compartments (skin, blood, lymph nodes, and viscera)
  • Median dose intensity was >95% for both the POTELIGEO and vorinostat treatment arms2

Duration of response (DOR) in POTELIGEO patients lasted 54% longer1

Bar chart: duration of response for Poteligeo versus vorinostat
  • The median DOR in patients treated with POTELIGEO was 13.9 months vs 9 months in vorinostat-treated patients
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

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Warnings and Precautions

  • Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
  • Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.
  • Infections: Monitor patients for signs and symptoms of infection and treat promptly.
  • Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
  • Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

  • The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).
  • 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.
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POTELIGEO is a registered trademark of
Kyowa Hakko Kirin Co., Ltd.
© 2018 Kyowa Kirin, Inc. All rights reserved.
PRC-MOG-0129 August 2018