Efficacy

An objective disease response was seen in up to 35% (25/71) of patients in 2 CTCL studies1

Response rates in study 1 and study 2a95% confidence interval.
Response rates above are rounded to the nearest whole number.
CR=complete response; ORR=objective disease response; PR=partial response.

SERIOUS ADVERSE REACTIONS

  • Infections were the most common type of serious adverse event reported in both studies with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection

 

The first FDA-approved treatment for CTCL to evaluate a global tumor (composite) response in all of the following disease sites1,18

The first FDA-approved treatment for CTCL to evaluate a global tumor (composite) response in the blood, skin, lymph nodes, and viscera

ISTODAX—for 2nd-line systemic therapy across
CTCL subtypes, including mycosis fungoides
and Sézary syndrome.1,2

A durable response was achieved with a median duration of response of 15 months (range: 1-20+a) and 11 months (range: 1-66+a)1

Median duration of objective responses in study 1 and study 2 aDenotes censored value.
DOR=duration of response.

  • Responses were evaluated in an advanced-stage population with 71% of patients in Study 1 and 87% of patients in Study 2 at stage IIB or greater1

SERIOUS ADVERSE REACTIONS (cont’d)

  • Serious adverse reactions reported in >2% of patients in Study 1 were sepsis and pyrexia (3%)
  • In Study 2, serious adverse reactions in >2% of patients were fatigue (7%), supraventricular arrhythmia, central-line infection, neutropenia (6%), hypotension, hyperuricemia, edema (5%), ventricular arrhythmia, thrombocytopenia, nausea, leukopenia, dehydration, pyrexia, aspartate aminotransferase increased, sepsis, catheter-related infection, hypophosphatemia, and dyspnea (4%)

ISTODAX demonstrated a durable response
in a population that included all disease
stages (IA-IVB) in 2 clinical studies1

A median time to objective disease response was seen in 2 months in 2 CTCL studies1

Median time to objective disease response in study 1 and study 2

 

Median time to complete response in Study 1 (N=96) and Study 2 (N=71)1

  • The median time to complete response was 4 months and 6 months in Study 1 (n=6) and Study 2 (n=4), respectively (range: 2-9 months)

SERIOUS ADVERSE REACTIONS (cont’d)

  • Most deaths were due to disease progression. In Study 1, there were two deaths due to cardiopulmonary failure and acute renal failure. In Study 2, there were six deaths due to infection (4), myocardial ischemia, and acute respiratory distress syndrome

Romidepsin (ISTODAX) has a category 2A
recommendation from the NCCN Guidelines®
for CTCL based on Study 1 and Study 2.10,18,19

NEXT: SAFETY

Important Safety Information

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Cutaneous T-Cell Lymphoma
The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).

Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.

The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%), and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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