The International Myeloma Foundation Says Pomalidomide, An Important New Drug For Patients, Has Been Submitted For FDA Approval

Pomalidomide is an oral drug that attacks the cancer in multiple ways, fighting the cells directly, as well as stimulating the immune system.

The International Myeloma Foundation (IMF) - the oldest and largest foundation dedicated to improving the life and care of myeloma patients - said a new drug for multiple myeloma has been submitted to the US Food and Drug Administration for approval. The drug, called pomalidomide, developed by CELGENE, would be used for patients with multiple myeloma who no longer respond to other therapies and would join the important, yet limited, number of drugs approved to fight this cancer. No new drugs have been approved for multiple myeloma in nearly six years.

"A proven new drug such as pomalidomide would fill the void left when patients have stopped responding to available drugs," said Susie Novis, President and Co-founder of the IMF. "New drugs such as REVLIMID(R) and VELCADE(R) have dramatically changed the course of treatment, giving patients longer remissions with a good quality of life. Because we don't have a cure yet, patients can work their way through the available treatments, which is why new options like pomalidomide are so important."

Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that affects the production of red cells, white cells and stem cells and can damage bone. It is growing in numbers and affecting increasingly younger people. Although multiple myeloma was once "a rare disease of the elderly," the IMF has recently been contacted by a patient in her early twenties and another still in his teens. Pomalidomide is an oral drug that attacks the cancer in multiple ways, fighting the cells directly, as well as stimulating the immune system. Clinical trials have demonstrated that pomalidomide is beneficial even in patients who have already stopped responding to multiple treatments.

"Pomalidomide is derived from the same science that brought us REVLIMID, but it is a distinct drug that can play an important role for patients," said Brian G.M. Durie, M.D., Chairman and Co-founder of the IMF. "Patients who have stopped responding to REVLIMID can have a sustained response and benefit from pomalidomide. This is a powerful drug, and once approved we expect it to play a key role in our tireless fight against myeloma."

Another new drug, called carfilzomib, was also submitted to the FDA at the end of last year and is undergoing review. Like pomalidomide, it works in many patients who have stopped responding to other treatments, but each drug works by a different mechanism of action. Other new developments include the introduction of injectable VELCADE to replace the intravenous infusion, and REVLIMID maintenance, which involves using drugs long-term, instead of stopping after a fixed number of cycles. Pomalidomide will also be submitted for approval in Europe later this year.

SOURCE: The International Myeloma Foundation