The FDA not only provided a breakthrough therapy designation for the drug — a combination of cytarabine and daunorubicin — it also offered an abbreviated 6-month priority review for the treatment.
“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s CDER. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.”
I asked the company how much this drug will cost. Their reply:
The cost of Vyxeos treatment will vary based on a patient’s size and the number of treatment cycles (induction and consolidation) utilized for the entire course of therapy. The Wholesale Acquisition Cost of Vyxeos per vial is $7,750. Based on the average patient size and the number of treatment cycles for patients in our Phase 3 study, we estimate that for approximately 80% of patients the Wholesale Acquisition Cost for the entire course of therapy would have been in the range of $46,500-$77,500.
Comparing their drug to the two separate components, the drug improved overall survival rates from 9.56 months vs. 5.95 months in a pivotal study with 309 patients.
Jazz snagged this drug in its $1.5 billion buyout of Celator a little more than a year ago.
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