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FDA Grants Accelerated Approval to Pomalidomide for Kaposi Sarcoma

It is approved in adult patients who are HIV-positive and HIV-negative
18 May 2020
Anticancer agents & Biologic therapy;  Cancer in Special Situations / Population;  Sarcomas

On 14 May 2020, the US Food and Drug Administration (FDA) expanded the indication of pomalidomide (POMALYST, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative.

Efficacy was investigated in Study 12-C-0047, an open-label, single-arm clinical trial, conducted by the US National Cancer Institute. Twenty-eight patients (18 HIV-positive, 10 HIV-negative) received 5 mg of pomalidomide orally once daily on days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. All HIV-positive patients continued highly active antiretroviral therapy.

The main efficacy outcome measure was overall response rate (ORR), which included complete response, clinical complete response, and partial response. Response was assessed by the investigator according to the AIDS Clinical Trial Group Oncology Committee response criteria for Kaposi sarcoma. Among the 18 HIV-positive patients, the ORR was 67% (95% confidence interval [CI] 41, 87) with a median response duration of 12.5 months (95% CI 6.5, 24.9). Among the 10 HIV-negative patients, the ORR was 80% (95% CI 44, 98) with a median response duration of 10.5 months (95% CI 3.9, 24.2).

The most common adverse reactions including laboratory abnormalities (≥30% of patients) who received pomalidomide were decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased haemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhoea.

The recommended pomalidomide dose for Kaposi sarcoma is 5 mg once daily taken orally with or without food on days 1 through 21 of each 28‑day cycle until disease progression or unacceptable toxicity. Continue highly active antiretroviral therapy as HIV treatment in patients with AIDS-related Kaposi sarcoma.

Full prescribing information for POMALYST is available here.

This indication is approved under accelerated approval based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Pomalidomide was granted priority review designation and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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