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Objective Response in CTCL: ZOLINZA Demonstrated Substantial Clinical Efficacy

In a Pivotal Trial, 30% of All Patients Achieved Objective Response

Objective response defined as a ≥50% decrease in SWAT score for at least 4 weeks

Median Time to Objective Response Was <2 Months (55 Days, Range: 28–171 Days)

  • However, in rare cases it took up to 6 months for patients to achieve an objective response to ZOLINZA.
  • Time to objective response was measured from the time treatment began until criteria were first met.

Efficacy Evaluated Using Stringent Criteria

  • Patients with less than a 50% decrease in SWAT scores (0%-49%) were considered nonresponders and excluded from the responder group.

Study Design

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

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.

SWAT Definition

SWAT Is an Objective, Quantitative, Severity-Weighted Assessment Tool
A SWAT score is derived by measuring each lesion as a percentage of total body surface area (%TBSA) and multiplying it by a severity-weighting factor (1=patch, 2=plaque, 4=tumor). All individual numbers are then added to produce a total score. Median baseline SWAT score was 73.7 (range: 1.5–366.0)

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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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