FDA approves Pomalyst multiple myeloma therapy

11th February 2013 (Last Updated February 11th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved advanced multiple myeloma therapy Pomalyst (pomalidomide) for patients whose disease progressed after being treated with other cancer therapeutics.

The US Food and Drug Administration (FDA) has approved advanced multiple myeloma therapy Pomalyst (pomalidomide) for patients whose disease progressed after being treated with other cancer therapeutics.

Pomalyst is designed to manipulate the body's immune system to destroy and inhibit the growth of cancerous cells.

FDA Center for Drug Evaluation and Research Hematology and Oncology Products office director Richard Pazdur said Pomalyst, the third drug in a class of immunomodulatory agents, which includes lenalidomide and thalidomide, and is the second multiple myeloma drug approved in the past year.

"Treatment for multiple myeloma is tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs," Pazdur said.

Pomalyst is indicated for patients who received a minimum of two prior therapies, including lenalidomide and bortezomib, and who have not responded to the treatment and progressed within 60 days of the previous treatment.

"Pomalyst is designed to manipulate the body's immune system to destroy and inhibit the growth of cancerous cells."

A trial of 221 patients with relapsed or refractory multiple myeloma, designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, ORR), assessed the safety and efficacy of Pomalyst.

Around 7.4% of patients treated with Pomalyst alone achieved ORR without reaching median duration of response, while 29.2% patients treated with Pomalyst plus low-dose dexamethasone achieved ORR with a 7.4-month median duration of response.

A decrease in infection-fighting white blood cells (neutropenia), fatigue and weakness, low red blood cell count (anaemia), constipation, diarrhoea, low levels of platelets in the blood (thrombocytopenia), upper respiratory tract infections, back pain and fever are the common side effects.

Celgene, based in Summit, New Jersey, the US, is marketing Pomalyst, lenalidomide and thalidomide.