Onyx Drug’s Mild Side Effects Let Myeloma Patients Stay on It

Onyx Pharmaceuticals Inc.’s experimental drug for multiple myeloma didn’t worsen nerve pain, a common side effect of current medicines, allowing patients to remain on treatment, studies showed.

The results came from 266 people enrolled in a trial of Onyx’s medicine who had previously developed mild or moderate neuropathy after taking Johnson & Johnson’s Velcade or Celgene Corp.’s Thalomid, according to research presented today at the American Society of Hematology meeting in Orlando, Florida. Less than 1 percent of the patients had their neuropathy worsen when they started taking Onyx’s drug carfilzomib, the study found.

Onyx, based in Emeryville, California, has said it plans to seek U.S. approval of carfilzomib in the middle of next year using the study and other results presented at the meeting. Onyx may have worldwide revenue of $391 million from the drug in 2015, Phil Nadeau, a New York-based analyst for Cowen & Co., said in a Nov. 4 note to investors.

“Peripheral neuropathy is arguably the biggest side effect problem in myeloma treatments today,” Michael Kauffman, Onyx’s chief medical officer, said in a Dec. 1 telephone interview. “It limits the use and duration of both Velcade and thalidomide and causes a great deal of misery for patients.”

Multiple myeloma, the second most common blood cancer, causes tumors to form in bone marrow and inhibits the immune system. In the U.S., 20,000 new cases are diagnosed each year, according to the National Cancer Institute.

Current Drugs

J&J’s Velcade and Celgene’s Thalomid cause nerve pain known as peripheral neuropathy in many patients, Kauffman said. Velcade had 2009 sales of $933 million and Thalomid had sales of $437 million last year, according to Bloomberg data.

The study was sponsored by Onyx and led by David Siegel, division chief for myeloma and lymphoma at the John Theurer Cancer Center at Hackensack University Medical Center in Hackensack, New Jersey.

A second company-funded analysis presented at the meeting yesterday looked at the rate of side effects among 505 patients who took part in different trials of the drug. Thirty-six patients died during the studies, 21 of them as a result of the disease itself. Deaths from use of carfilzomib were “uncommon,” according to the study, without providing a number.

The most common serious adverse events to emerge during the trials were reductions in blood platelets, red blood cells and white blood cells, each experienced by about 20 percent of patients, the research said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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