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Fda approves Tagrisso (osimertinib, Osimtinib), a third-generation EGFR inhibitor developed by AstraZeneta, as the first complementary therapy to treat patients with non-small cell lung cancer (NSCLC) with specific types of gene mutations in tumors.
, director of the FDA's Center for Advanced Research in Oncology, said: "Tagrisso's approval today could allow more NSCLC patients to receive this targeted therapy at an earlier stage of the disease.
" in a randomized two-blind and placebo-controlled trial involving 682 patients, a total of 339 patients took Tagrisso once a day or so, and 343 patients received a placebo after recovery from surgery and standard assisted chemotherapy.
, patients who took Tagrisso had an 80 percent lower recurrence rate than those who received a placebo, according to the study.
is one of the most common cancers in the world and the leading cause of cancer-related deaths worldwide.
non-small cell lung cancer accounts for about 80% of all lung cancers.
, about 20% of patients with non-small cell lung cancer carry a skin growth factor subject (EGFR) mutation.
the United States, about 229,000 people will be diagnosed with lung cancer by 2020, 76% of them non-small cell lung cancer.
about 20 percent of patients with non-small cell lung cancer will have a skin growth factor subjector (EGFR) mutation, a protein mutation that causes rapid cell growth to help spread the cancer.
about 30 percent of non-small cell lung cancer patients with tumors can be surgically removed, and these patients may be Tagrisso candidates for complementary treatment after tumor removal.
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