POTELIGEO was studied in a large clinical trial. POTELIGEO was studied in people who tried at least 1 prior medicine (taken by mouth or injection) that did not work or whose Mycosis Fungoides (MF) or Sézary Syndrome (SS) had come back or spread.

The trial looked at how POTELIGEO worked compared against another treatment called vorinostat.

POTELIGEO helped slow the spread of Mycosis Fungoides (MF) or Sézary Syndrome (SS)

When talking about POTELIGEO, your doctor may say:
Progression-free survival (PFS)

Which means:
How well treatment prevented Mycosis Fungoides (MF) or Sézary Syndrome (SS) from spreading further

POTELIGEO: 7.6 months. vorinostat: 3.1 months. Median number of months that Mycosis Fungoides (MF) or Sézary Syndrome (SS) was controlled before showing any sign of spreading further 7.6months 3.1months POTELIGEO vorinostat

Median number of months that Mycosis Fungoides (MF) or Sézary Syndrome (SS) was controlled before showing any sign of spreading further

POTELIGEO: 7.6 months. vorinostat: 3.1 months. POTELIGEO vorinostat 7.6 months 3.1 months
  • POTELIGEO was shown to slow the spread of Mycosis Fungoides (MF) or Sézary Syndrome (SS) on the skin and in the blood
  • POTELIGEO stopped disease from worsening for more than 2 times as long as those not on POTELIGEO
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More people responded to treatment with POTELIGEO

When talking about POTELIGEO, your doctor may say:
Overall response rate (ORR)

Which means:
How well Mycosis Fungoides (MF) or Sézary Syndrome (SS) responded to treatment in areas of the body where disease was found when entering the trial

Overall response rate POTELIGEO vs vorinostat POTELIGEO showing response in five people compared to one person with vorinostat POTELIGEO vorinostat

More than 5 times as many people (28%) were classified as responders to treatment with POTELIGEO than with vorinostat (5%)

How POTELIGEO clinical trial results were measured

Response in skin

More than 2 times as many people on POTELIGEO saw their skin improve

POTELIGEO

0 %

RESPONDED

VS

vorinostat

0 %

RESPONDED

Response in blood

Nearly 4 times as many people on POTELIGEO saw a lower cancerous T-cell count in their blood

POTELIGEO

0 %

RESPONDED

VS

vorinostat

0 %

RESPONDED

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People responded faster to POTELIGEO

When talking about POTELIGEO, your doctor may say:
Time to response (TTR)

Which means:
How long it took people to respond to treatment

Overall, people who responded to treatment with POTELIGEO did so almost
2 months faster than those treated with vorinostat

Response to treatment was almost
2 months faster
POTELIGEO clinical trial time to response (median)
  • People treated with POTELIGEO saw a median response in blood in 1.1 months and response in skin in 3.0 months
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POTELIGEO worked longer than vorinostat

When talking about POTELIGEO, your doctor may say:
Duration of response (DoR)

Which means:
How long people responded to treatment

Duration of response, POTELIGEO vs vorinostat Of people in the trial who responded to treatment, response lasted longer in people taking POTELIGEO compared with those taking vorinostat 13.9months 9.0months POTELIGEO vorinostat

Of people in the trial who responded to treatment, response lasted longer in people taking POTELIGEO compared with those taking vorinostat

Duration of response, POTELIGEO vs vorinostat POTELIGEO vorinostat 13.9 months 9.0 months
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Educate yourself on important treatment considerations
Learn more about treatment with POTELIGEO

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

  • Skin problems: Signs and symptoms of skin reactions may include skin pain, itching, skin blistering or peeling, rash, painful sores or ulcers in your mouth, nose, throat or genital area.
  • Infusion reactions: Signs and symptoms of infusion reactions may include chills or shaking, redness on your face (flushing), itching or rash, shortness of breath, coughing or wheezing, dizziness, feeling like passing out, tiredness, fever.
  • Infections: Signs and symptoms of infection may include fever, sweats or chills, nausea, flu-like symptoms, sore throat or difficulty swallowing, shortness of breath, diarrhea or stomach pain, cough.
  • Autoimmune problems: Some people receiving POTELIGEO may develop autoimmune problems, and some people who already have an autoimmune disease may get worse during treatment with POTELIGEO.
  • Complications of stem cell transplant: Patients who receive a stem cell transplant using donor stem cells (allogeneic) after treatment with POTELIGEO may experience complications that can be severe and lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

What are the most common side effects of POTELIGEO?

The most common side effects of POTELIGEO include rash, tiredness, diarrhea, muscle and bone pain, and upper respiratory tract infection.

Before starting POTELIGEO treatment, tell your doctor about all your medical conditions, including whether you:

  • have had a severe skin reaction after receiving POTELIGEO
  • have had an infusion reaction during or after receiving POTELIGEO
  • have or have had liver problems including hepatitis B (HBV) infection
  • have a history of autoimmune problems
  • have undergone or plan to have a stem cell transplant, using cells from a donor
  • have lung or breathing problems
  • are pregnant or plan to become pregnant
    - It is not known if POTELIGEO will harm your unborn baby
  • are breastfeeding or plan to breastfeed
    - Talk to your healthcare provider about the best way to feed your baby during treatment with POTELIGEO

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

Please see full Prescribing Information as well as Patient Information.