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FDA approved Pomalyst (pomalidomide) for Multiple Myeloma and Kaposi SarcomaFDA approved new drug Pomalyst for multiple myeloma and Kaposi sarcoma.

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Key Takeaway
Consider Pomalyst for heavily pretreated multiple myeloma or Kaposi sarcoma after prior therapy failure.

The FDA has approved Pomalyst (pomalidomide), a thalidomide analogue, for two indications. In multiple myeloma, it is indicated in combination with dexamethasone for adult patients 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. For Kaposi sarcoma, Pomalyst is approved for AIDS-related KS after failure of HAART and for HIV-negative patients with KS. The KS indication received accelerated approval based on overall response rate; continued approval may depend on confirmatory trials. This approval provides a new treatment option for heavily pretreated multiple myeloma patients and for Kaposi sarcoma patients with limited alternatives.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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.

Place in Therapy

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.

The FDA has approved a new drug called Pomalyst (pomalidomide) for two serious diseases: multiple myeloma and Kaposi sarcoma. Multiple myeloma is a cancer of plasma cells in the bone marrow. Kaposi sarcoma is a cancer that causes tumors in the skin, lymph nodes, or other organs, often in people with AIDS. Pomalyst is a type of drug called a thalidomide analogue. It works by affecting the immune system and stopping cancer cells from growing.

For multiple myeloma, Pomalyst is used together with another drug called dexamethasone. It is for adults who have already tried at least two other treatments, including lenalidomide and a proteasome inhibitor, and whose cancer got worse during or within 60 days of their last treatment. For Kaposi sarcoma, Pomalyst is approved for patients with AIDS-related Kaposi sarcoma that did not get better with HIV treatment, and for patients without HIV who have Kaposi sarcoma. This approval for Kaposi sarcoma was based on how many patients responded to the drug, but more studies are needed to confirm the benefit.

This approval gives new hope to patients who have few other options. However, it is important to remember that every patient is different. Pomalyst has side effects, and it may not work for everyone. Patients should talk to their doctor to see if Pomalyst is a good choice for their specific situation.

What this means for you:
Pomalyst is a new FDA approved drug for certain patients with multiple myeloma or Kaposi sarcoma.

Study Details

Study typeFda approval
PublishedFeb 2013
View Original Abstract ↓
1 INDICATIONS AND USAGE POMALYST is a thalidomide analogue indicated for the treatment of adult patients: • in combination with dexamethasone, 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 ( 1.1 ). • with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) ( 1.2 ). 1.1 Multiple Myeloma POMALYST, in combination with dexamethasone, is indicated for adult 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. 1.2 Kaposi Sarcoma POMALYST is indicated for the treatment of: • Adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART). • Kaposi sarcoma (KS) in adult patients who are HIV-negative. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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