Tue, May 21, 2013 - Page 5 News List

FDA to approve new lung cancer drug

By Alison Hsiao  /  Staff reporter

A new targeted therapy drug, afatinib, is set to be approved by the Food and Drug Administration (FDA) to treat lung cancer patients.

Taiwan, as the lead executor of several of the clinical trials, is expected to be the first country to have the drug available on the market.

The clinical trials of afatinib were conducted in several countries worldwide, the Department of Health said.

Taiwan has six medical centers working on researching the drug: National Taiwan University Hospital, Tri-Service General Hospital, National Cheng Kung University Hospital, Chang Gung Memorial Hospital in New Taipei City’s (新北市) Linkou District (林口), Chiayi Chang Gung Memorial Hospital and Taipei Veterans General Hospital.

The health department said the new drug is more effective than chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor tyrosine kinase mutation and prolongs the progression free survival time.

“[By] more broadly and effectively blocking the molecular pathways that facilitate the growth of these cancers, afatinib appears to be more potent than other therapies,” National Taiwan University professor James Yang (楊志新), the principal investigator of the study, was quoted in the press briefing of last year’s annual meeting of the American Society of Clinical Oncology as saying.

“[This] new treatment could not only help patients live a longer period of time without further cancer progression, but because it’s given orally, it may also require fewer visits to the doctors’ office than standard chemotherapy — another important quality of life advantage,” he said.

However, patients treated with afatinib sometimes experienced side effects, such as diarrhea and rashes, the FDA said.

Doctors can familiarize themselves with the drug by following a risk management plan that offers information about the safety of the drug and the factors which may cause side effects, the agency added.

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