FDA Approves Pomalyst (pomalidomide) for Multiple Myeloma and Kaposi Sarcoma

Pomalidomide is a thalidomide analogue. Its mechanism of action is not fully described in the label.

Pomalyst is indicated for adult patients with multiple myeloma 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. It is also indicated for adult patients with AIDS-related Kaposi sarcoma after failure of HAART, and for Kaposi sarcoma in HIV-negative adult patients.

For multiple myeloma: 4 mg orally once daily on Days 1 through 21 of repeated 28-day cycles until disease progression. Administer with dexamethasone per clinical study. For Kaposi sarcoma: 5 mg orally once daily on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity. Continue HAART in AIDS-related KS. Dosage modifications are required for hematologic adverse reactions and for patients with renal or hepatic impairment.

Trial data not available in label.

Pomalyst is a thalidomide analogue. Females of reproductive potential must have negative pregnancy testing and use contraception before initiating therapy. Hematologic adverse reactions including neutropenia and thrombocytopenia require dose modifications. Specific warnings and contraindications are detailed in the label.

Pomalyst provides a treatment option for heavily pretreated multiple myeloma patients who have progressed on lenalidomide and a proteasome inhibitor. For Kaposi sarcoma, it offers a therapy after HAART failure in AIDS-related cases and for HIV-negative patients, with accelerated approval pending confirmatory trials.