The Food and Drug Administration announced Nov. 13 its approval of Imbruvica, an expensive drug designed to treat Mantle Cell Lymphoma in patients who have previously undergone at least one type of treatment already. Jesse McGreivy, chief medical officer of Pharmacyclics, Inc., said Imbruvica — generically known as ibrutinib — is the first drug for which the company has received FDA approval.
MCL is one of many types of lymphoma, the most common form of blood cancer, and occurs in B-cells, a type of white blood cells.
Imbruvica works by inhibiting an enzyme called Bruton’s tyrosine kinase that plays an important role in the growth and survival of malignant cells.
The University Health System participated in clinical trials for Imbruvica, testing both its safety and effectiveness, and will begin using it to treat patients.
Asst. Internal Medicine Prof. Michael Douvas said trials at the University showed positive results.
“Mantel cell lymphoma patients [being treated with Imbruvica] overcome non-Hodgkin lymphoma with relatively few side effects,” Douvas said.
But the drug’s success is matched by its high price tag. According to a “New York Times Magazine” report, Imbruvica will cost about $90 a pill. By taking the recommended dosage of four pills a day, a year’s worth of treatment could cost upwards of $130,000.
Chronic lymphocytic leukemia can also be treated with Imbruvica and requires fewer pills, lowering the average yearly cost for patients to about $98,400 a year. The high pricing is because of a current law allowing drug companies to patent the products they produce, rather than the production process, eliminating direct competitors that could drive prices down.
Robert W. Duggan, chief executive of Pharmacyclics, told The New York Times that his company spent almost $1 billion to bring Imbruvica to market. Still, the company admits that the price may just be too much for some, and plans to offer financial assistance to many patients.
“I have patients from all walks of life,” Douvas said. “Some get covered by government programs, some through programs by the hospital, and some get covered through their companies. We can apply to programs and they usually come through for people.”
The University Health System is currently conducting tests to see what, if any, other medications can be used in conjunction with Imbruvica for better, safer treatments. Because clinical trials of Imbruvica began only two years ago, no data exists regarding its long-term effects.
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