Pomalidomide receives accelerated approval to for Kaposi sarcoma

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has expanded the indication of pomalidomide (Pomalyst) to include adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, and Kaposi sarcoma in adult patients who are HIV-negative.

Pomalyst is sponsored by Celgene Corp.

Efficacy was investigated in Study 12-C-0047, an open-label, single-arm clinical trial, conducted by NCI. 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, 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% 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).

Table of Contents

YOU MAY BE INTERESTED IN

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 
The American Cancer Society’s recent report on the increasing incidence rates of colorectal cancer in young adults once again rang an alarm bell for adults over 45 to get checked, especially if they are having symptoms. But as an oncologist with more than 40 years of experience, I also believe that this should be a clarion call to scientists and researchers, and for regulators at the FDA.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login