Entremed (ENMD)

[RRGY2K]

The Federal Drug prevention Agency wonders about Avastin. I do too, considering that Panzem kept some patients alive and almost symptom free before they were kicked out of the trials to die under lesser therapies. I also wonder how FDA people sleep at night when they spend their days obstructing the only treatment possibilities of patients without options.


"WASHINGTON (AP) -- Federal health regulators said Friday it's unclear whether Genentech's blockbuster cancer drug Avastin significantly shrinks the deadliest type of brain tumor.
The Food and Drug Administration is reviewing the company's drug for patients with recurring glioblastoma multiforme, a form of brain cancer that is generally fatal within six months.

South San Francisco, Calif.-based Genentech has asked the FDA to give its drug accelerated approval. That designation gives market access based on promising early results.

However regulators said in documents posted online that they are unsure that the company's results are strong enough to rush out the new indication.

The company's application relies on imaging scans that claim to show a reduction in tumor size. Patients were considered responsive to the drug if their tumor shrunk at least 50 percent over the course of two consecutive visits to their physician. In two separate studies, Genentech reported that roughly 25 percent and 20 percent of brain cancer patients responded successfully to the drug.

However, FDA reviewers said they have never used "response rate" as a measurement to grant accelerated approval for a brain cancer drug. They noted the difficulty of measuring tumor size via medical imaging.

Avastin is also known to decrease swelling caused by excess fluid in the brain, which could give the false impression of tumor reduction, reviewers noted.

FDA's panel of outside cancer experts previously stated that a drug would have to have a response rate above 30 percent -- higher than either of Genentech's studies -- to outweigh the uncertainties connected with brain tumor imaging.

Next Tuesday the FDA will ask its panel to weigh in on whether Avastin should be granted accelerated approval for patients whose brain cancer has returned. The agency is not required to follow the panel's advice, though it usually does."

http://finance.yahoo.com/news/FDA-questions-studies-of-apf-14765598.html