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FDA Approves New Drug for Advanced Lung Cancer

Gilotrif targets a gene mutation that occurs in about 10 percent of cases
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WebMD News from HealthDay

By Robert Preidt

HealthDay Reporter

FRIDAY, July 12 (HealthDay News) -- A new drug to treat advanced lung cancer has been approved by the U.S. Food and Drug Administration.

Gilotrif (afatinib) is approved to treat patients with a specific subtype of of non-small cell lung cancer (NSCLC). About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer.

Gilotrif is approved to treat tumors that carry key deletions on the epidermal growth factor receptor (EGFR) gene, long a target for lung cancer therapeutics. Mutations in the EGFR gene are thought to occur in about 10 percent of non-small cell lung cancers, and most of those mutations are targeted by Gilotrif, the FDA said.

Experts were pleased with the drug's approval.

"This drug represents a new important alternative to standard chemotherapy in the 10 to 15 percent of lung cancer patients who have EGFR mutations," said Dr. Jorge Gomez, medical director of the thoracic oncology program at Mount Sinai Medical Center in New York City. The new medication "is the first drug to be developed and approved for patients selected for EGFR mutations," he pointed out.

Dr. Len Horovitz is a pulmonary specialist at Lenox Hill Hospital in New York City. He explained that the "genetic evaluation of lung cancer tissue has evolved so that newer mutations can be targeted in treatment," and new drugs such as Gilotrif "complement standard chemotherapy [and] give hope of increased survival even in late stage lung cancer."

Gilotrif is in a class of cancer drug called tyrosine kinase inhibitors. These drugs block proteins that promote the development of cancerous cells.

According to the FDA, Gilotrif was approved alongside the therascreen EGFR RGQ PCR Kit -- a companion diagnostic that helps determine if a patient's lung cancer cells express these EGFR mutations.

Gilotrif's approval was based on a clinical study of 345 patients who were randomly assigned to receive either Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin. Patients who received Gilotrif had a delay in tumor growth (progression-free survival) that was more than four months longer than those who received chemotherapy. However, there was no statistically significant difference in overall survival between the two groups of patients, the FDA said.

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