In the MAVORIC phase 3 clinical trial…

POTELIGEO demonstrated higher response rates in skin, blood, and lymph nodes1,2a

Skin response rate

Bar chart: skin response rate for Poteligeo (42%) versus vorinostat (16%)
  • Skin response was evaluated using the modified Severity Weighted Assessment Tool (mSWAT) based on visual inspection of the skin
  • Responses in skin must have persisted for ≥4 weeks to be confirmed and were evaluated every 4 weeks

Skin duration of response (months, median)

Bar chart: skin duration of response for Poteligeo (20.6 months) vs vorinostat (10.7 months)

Blood response rate

Bar chart: blood response rate for Poteligeo (67%) versus vorinostat (18%)
  • Blood response was assessed by central flow cytometry
  • Responses in blood must have persisted for ≥4 weeks to be confirmed and were evaluated every 4 weeks

Blood duration of response (months, median)

Bar chart: blood duration of response for Poteligeo (25.5 months) versus vorinostat (not estimable)

Lymph nodes response rate

Bar chart: lymph node response rate for Poteligeo (15%) versus vorinostat (4%)
  • Response in lymph nodes were determined based upon size criteria and evaluated by computed tomography (CT) scans at 4 weeks, then every 8 weeks in Year 1 and every 16 weeks thereafter.

Lymph nodes duration of response (months, median)

Bar chart: lymph node duration of response for Poteligeo (15 months) versus vorinostat (not estimable)

Viscera response rate

Bar chart: viscera response rate for Poteligeo (0%) versus vorinostat (0%)
  • There was no difference in response in viscera
  • Response in viscera were determined based upon size criteria and evaluated by CT scans at 4 weeks, then every 8 weeks in Year 1 and every 16 weeks thereafter

Viscera duration of response (months, median)

Bar chart: viscera duration of response for Poteligeo (0 months) versus vorinostat (0 months)
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.
© 2019 Kyowa Kirin, Inc. All rights reserved.
PM-US-POT-0042 July 2019