Introgen files for FDA approval of cancer drug

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Introgen Therapeutics Inc. announced on Thursday that it has filed a request with the U.S. Food and Drug Administration for approval of its cancer drug, Advexin.

The company, based in Austin, says its based that filing on positive results from two recent drug trials focused on patients with head and neck cancer.

"We have based our accelerated regulatory submission strategy upon recent analyses of currently available Advexin clinical data,” says Max Talbott, Introgen’s senior vice president of worldwide regulatory and commercial development. “From the perspective of patients with few options, we believe that it is advantageous to seek accelerated approval for Advexin.”

The company has spent more than a decade and a half billion dollars researching and developing an anti-cancer drug.

The FDA approval process could take up to 18 months.

In 2003, Introgen’s investigational drug, Advexin, was granted “fast track” designation by the U.S. Food and Drug Administration as a treatment for head and neck cancer, which could reduce the time the FDA takes is reviewing Introgen’s application.

Introgen develops biopharmaceutical products for the treatment of cancer and other diseases. The company conducts research, development, manufacturing, clinical and regulatory activities at its Austin headquarters, where it employs about eight people. 

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