FDA's First Approval of Lung Cancer Drugs for Six Years

The US Food and Drug Administration recently approved the listing of a new lung cancer drug developed by Pfizer in the United States through a simplified procedure. This is the first time in six years that the FDA has approved the listing of lung cancer drugs.

The new drug name is Xalkori, a kinase inhibitor suitable for patients with advanced or local metastasis of non-small cell lung cancer with abnormal expression of an interstitial lymphokine kinase gene, and can be used to block multiple functions that are critical for the growth and survival of tumor cells. The cellular pathway allows the tumor to stabilize or subside.

Mutation of the anaplastic lymphoma kinase gene is considered to be a key factor in the development of cancer such as non-small cell lung cancer, and about 1% to 7% of non-small cell lung cancer patients have abnormal expression of a variant lymphoma kinase gene. Such patients are usually not smokers.

In two clinical trials, the drug significantly alleviated the symptoms of NSCLC patients, with a median duration of remission of more than 40 weeks. However, there is no data showing that this drug can improve the survival rate of patients. As part of the post-marketing requirements, Pfizer will continue to carry out Phase III clinical trials to further confirm its effectiveness.

Non-small cell lung cancer accounts for 85% of all lung cancers. At present, this type of cancer is difficult to treat. About 75% of NSCLC patients are advanced or transferred to other sites when they are diagnosed. The 5-year survival rate is only 6%.