The US health regulator has approved Eli Lilly drug for the treatment of a rare form of blood cancer.
The Food and Drug Administration, FDA’s said the wholesale cost of the treatment, Jaypirca, will be $21,000 per 30 days for the 200 mg dose.
Its accelerated approval for Jaypirca marks the first of the five treatments the U.S. drugmaker hopes to launch this year, including one for obesity.
The drug, which is expected to be available in the United States in the coming weeks, aims to treat adults with mantle cell lymphoma after at least two lines of therapy. Mantle cell lymphoma is a rare type of blood cancer that starts in white blood cells in the lymph nodes and aggressively spreads to other parts of the body.
Jaypirca’s approval is based on data from a subset of 120 patients in an early-to-mid stage trial that showed half of them responded to the drug, while 13% achieved a complete response.
The trial assessed the efficacy of 200 mg dose of the drug until disease progression or unacceptable toxicity.
The FDA last week had rejected an accelerated approval of Lilly’s experimental Alzheimer’s drug donanemab because the company had not submitted enough trial data from patients who were treated for at least a year.
VON