Small Cell Lung Cancer
Pharmacyclics Receives Refuse to File Letter for Xcytrin
Published in Medical Letter on the CDC and FDA, March 11th, 2007
In the letter, the FDA stated that the company's application is not sufficiently complete to permit a substantive review based on clinical studies that failed to demonstrate statistically significant differences between treatment arms in the primary endpoints.
"We will be evaluating our options with Xcytrin for the brain metastases indication...
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