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The drug maker Eli Lilly announced the U.S. Food and Drug Administration (FDA) has approved the drug in combination with cisplatin, a standard chemotherapy drug, for patients with locally advanced and metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.
The news comes shortly after the company’s Friday announcement which said that the FDA needs more time to review its application for the blood thinner and this was the second time the regulatory agency asked for additional time.
Therefore the stock fell $1.56, or 3.3 percent, to $45.26 in midday trading. Shares have traded between $43.81 and $59.82 over the past year, according to Forbes.
The cancer drug is called Alimta and was initially approved by the FDA back in 2004 for the treatment of malignant pleural mesothelioma.
NSCLC is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma, large cell carcinoma and all other histologies except squamous cell carcinoma.
Lilly won the new approval battlewith Alimta after comparing it to another Lilly cancer drug, Gemzar, in a Phase III clinical trial that involved 1,725 patients. Tests showed a 27.1% overall response rate for combination therapy of Alimta and cisplatin, versus 24.7% for the existing Gemzar and cisplatin. According to the studies, patients treated with Alimta regimen had less hematologic toxicity, fewer blood transfusions and decreased use of growth factors compared to those treated with Gemzar.
During the first half of this year, sales increased 32 percent from the same period last year.
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