FDA Approves Eli Lilly's Lung Cancer Drug

The U.S. Food and Drug Administration on Tuesday said it approved Eli Lilly's drug to treat a form of the most common type of lung cancer.

Portrazza can be used in combination with two forms of chemotherapy to treat patients with advanced squamous non-small cell lung cancer who haven't previously received medication specifically for treating their advanced lung cancer. Portrazza, or necitumumab, is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors.

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the FDA. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer—squamous cell and non-squamous cell.

"Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

He said the treatment approved Tuesday provides certain patients a new option that may extend survival.

In a multicenter, randomized, open-label clinical study of 1,093 participants, patients who were taking Portrazza in combination with chemotherapy were found to live an average of 11.5 months compared with 9.9 months for patients who were only receiving chemotherapy.

The most common side effects were skin rash and magnesium deficiency, which can cause muscular weakness, seizure and irregular heartbeats, and can be fatal. Risks include cardiac arrest and sudden death.

Shares of Eli Lilly, up about 21% this year, were down 1.3% in midday trading.

Write to Anne Steele at [e-mail]

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(END) Dow Jones Newswires

November 24, 2015 13:05 ET (18:05 GMT)

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