Onyx Pharmaceutical has received approval from the US Food and Drug Administration to begin selling its multiple myeloma drug, known as Kyprolis (carfilzomib).
The FDA approved Kyprolis for a narrow patient population: for those multiple myeloma patients who have received two prior therapies (notably, those therapies are Revlimid and Velcade).
“We think this is just terrific for patients,” said Onyx CEO Tony Coles. “We are prepared to launch, we have all the necessary plans in place.”
Cost of treatment
The question of how much the average treatment will cost the patient came up during a phone conference, and the company's CCO said that therapy with Kyprolis will cost $9,950 for a 28-day cycle.
Since patients in the trial that gained market approval for the treatment were found to require a median of 4.4 months, this puts the cost of Kyprolis in excess of $40,000 for a complete treatment regimen.
According to published data, Kyprolis was found to be effective in reducing tumor size in approximately twenty-two percent of multiple myeloma patients.
Risks of treatment
The treatment's toxic profile appears to be pretty severe, with reports of cardiac arrest, chest pain, pneumonia and shortness of breath. On top of that, seven out of every ten patients taking the medication in clinical trials would later report experiencing lung complications, leading one to believe the drug is pneumotoxic.
The latest estimates put the number of multiple myeloma patients in the United States at around 50,000, with 20,000 new diagnoses made each year. Approximately 11,000 people die from the disease annually.