Onyx expects to file myeloma drug at FDA this year

CHICAGO (Reuters) - Onyx Pharmaceuticals Inc expects to file later this year for regulatory approval of its experimental cancer drug carfilzomib, according to the company’s chief executive officer.

The filing, based on results from a single-arm study, would be for severely ill multiple myeloma patients whose cancer has gotten worse after an average of five prior treatment regimens, CEO Tony Coles told Reuters in an interview.

“Our first objective is people whose disease has progressed despite Velcade,” he said, referring to the Takeda Pharmaceutical Co drug for the cancer that develops in cells of the bone marrow.

Last year, Onyx acquired carfilzomib developer Proteolix Inc for an upfront cash payment of $276 million and potential milestone payments of up to $535 million.

Coles said the data that will be used for the regulatory application comes from an extension of a mid-stage trial begun by Proteolix.

Top-line results from the trial are expected later this year.

“We would file the NDA (new drug application) by year-end and will request accelerated approval,” Coles said. “It could be on the market in 2011.”

Interim trial data presented here at a meeting of the American Society of Clinical Oncology showed that 55 percent of patients not previously treated with Velcade responded to the highest studied dose of the Onyx drug.

Side effects included pneumonia, anemia and low white blood cell levels.

“The data suggest this drug will have a place in multiple myeloma treatment,” Coles said.

Regulators have approved plans for a Phase 3 trial of carfilzomib in combination with other drugs in patients with earlier stage myeloma, he said.

Onyx also expects to report results from a lung cancer trial of Nexavar, co-marketed with Bayer AG.

“Most people expect the results to be negative,” following the earlier failure of a similar trial, Coles said.

But he believes a change in the chemotherapy regimen used in the latest trial as well as fine-tuning of the patient population have increased the odds of success.

Earlier this year, a trial of Nexavar in melanoma patients was stopped when it became clear that the drug was not providing a benefit.

Nexavar, approved to treat liver and kidney cancers, posted sales of $201 million in the second quarter.