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Zolinza® [vorinostat] capsules Reactivate Expression
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Pivotal Study: Efficacy Evaluated in Advanced CTCL

Patients in Clinical Trials of ZOLINZA Were Heavily Pretreated

  • Eligible patients had been treated with at least 2 systemic therapies.
  • Median number of prior systemic therapies was 3 (range: 1–12).
  • Enrolled patients should have received, been intolerant of, or not been a candidate for bexarotene.
Prior Therapy N %
Bexarotene 71 95.9
Interferon 47 63.5
Chemotherapy 45 60.8
Photopheresis 27 36.5
Denileukin diftitox 23 31.1

Response to Previous Systemic Therapy Does Not Appear to Be Predictive of Response to ZOLINZA

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Majority of Patients Had Stage IIB or Higher CTCL at Baseline

CTCL Stage N %
IB 11 15
IIA 2 3
IIB 19 26
III 22 30
IVA 16 22
IVB 4 5

Additional Patient Characteristics

Age, Gender, and Race
Patients studied were aged 39 to 83 years (median 60 years); 48.6% female and 51.4% male; 82.4% white, 14.9% black, 1.4% Asian, and 1.4% other.

Study Design

Open-label, single-agent, multicenter trial in patients (N=74) treated with ZOLINZA 400 mg once daily.

Objective response (primary end point)=either complete clinical response (CCR), defined as no evidence of disease, or partial response (PR), defined as a ≥50% decrease in SWAT skin assessment score compared with baseline. Both CCR and PR had to be maintained for at least 4 weeks.

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Selected Important Safety Information

  • Pulmonary embolism and deep vein thrombosis have been reported. Monitor patients for pertinent signs and symptoms, particularly in patients with a history of thromboembolic events.
  • Treatment with ZOLINZA can cause dose-related thrombocytopenia and anemia. If platelet counts and/or hemoglobin are reduced during treatment, modify the dose or discontinue therapy.

Before prescribing ZOLINZA, please read the physician Prescribing Information. The Patient Product Information is also available.

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