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news.Pharmacyclics has received a refuse to file letter from the US Food and Drug Administration for the company's application for new drug Xcytrin injection, citing the application as incomplete.
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The company is developing Xcytrin as an anti-cancer agent for the treatment of non-small cell lung cancer patients with brain metastases. The FDA stated that the company’s application is not sufficiently complete to permit a substantive review.
US authorities said Pharmacyclics’ clinical studies, which the application was based on, 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 and determine the best path forward,” said Richard Miller, managing director, president and CEO of Pharmacyclics.
“Beyond this indication, the clinical development program with Xcytrin continues on multiple fronts. Several ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development,” added Mr Miller.