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The U.S. Food and Drug Adminstration Approves Pharmacyclics Product For Treatment of Disease

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The U.S. Food and Drug Adminstration Approves Pharmacyclics Product For Treatment of Disease

On Wednesday, the U.S. Food and Drug Administration reported on its website that it has approved Imbruvica for the treatment of rare blood cancer. Imbruvica is co-marketed by Pharmacyclics (NASDAQ: PCYC).

According to the FDA, Imbruvica is intended for patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. By the time the disease is diagnosed, it has already spread to the lymph nodes, bone marrow and other organs.

Pharmacyclics received accelerated approval following a study where 111 participants were given Imbruvica daily until the disease progressed or side effects became intolerable. Sixty-six percent of the participants had their cancer shrink or disappear during the trials.

Shares of Pharmacyclics were halted shortly after 12:00PM ET. A conference call took place at 1:00PM where management announced that Imbruvica will be commercially available immediately at a price of $130,000 a year, above an estimated $110,000 price tag for the treatment.

Shares resumed trading at 1:10PM, rising to $121.30. Shares continued to gain throughout the afternoon, hitting a daily high of $129.35.

Posted-In: News FDA Legal Markets Best of Benzinga

 

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