What’s the most critical endpoint?
Over all, it’s survival.
The FDA recognizes overall survival (OS) as the
most reliable and preferred cancer endpoint.
OS is an unbiased, objective endpoint that is
precise in its measurement. 1
Indication
POMALYST ® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone
(dex), for patients with multiple myeloma (MM) who have received at least two prior therapies including
lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days
of completion of the last therapy.
POMALYST is only available through a restricted distribution program, POMALYST REMS ® .
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
• POMALYST is contraindicated in pregnancy.
POMALYST is a thalidomide analogue.
Thalidomide is a known human teratogen that
causes severe birth defects or embryo-fetal
death. In females of reproductive potential,
obtain 2 negative pregnancy tests before
starting POMALYST treatment.
• Females of reproductive potential must use
2 forms of contraception or continuously
abstain from heterosexual sex during and for
4 weeks after stopping POMALYST treatment.
POMALYST is only available through a restricted
distribution program called POMALYST REMS ® .
Venous and Arterial Thromboembolism
• Deep venous thrombosis (DVT), pulmonary
embolism (PE), myocardial infarction, and stroke
occur in patients with multiple myeloma treated
with POMALYST. Prophylactic antithrombotic
measures were employed in clinical trials.
Thromboprophylaxis is recommended, and the
choice of regimen should be based on assessment
of the patient’s underlying risk factors.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confi dence interval; CrCl, creatinine clearance;
DVT, deep venous thrombosis; HR, hazard ratio; ITT, intent-to-treat; OS, overall survival; PE, pulmonary embolism;
PFS, progression-free survival; PI, proteasome inhibitor.
*Data cutoff: March 1, 2013.
Please see brief summary of full Prescribing Information, including Boxed WARNINGS, and additional
Important Safety Information on the following pages.