Pharmaprojects R&D Pipeline News Feed
FDA puts a dampener on Pharmacyclics' Xcytement
1st Mar 2007
Following submission of an NDA in January of this year, Pharmacyclics has received a refuse to file letter from the US FDA for its application for its new chemo/radio-sensitizer, Xcytrin injection (motexafin gadolinium). The submission was filed for use as an anticancer agent in non-small cell lung cancer patients with brain metastases.
Citing the applications as incomplete, the FDA stated that clinical trial data included in the application failed to demonstrate statistically-significant differences between treatment arms in primary endpoints.
Although the news is disappointing, Pharmacyclics' President and CEO Richard A Miller remained positive, saying: "We will be evaluating our options with Xcytrin for the brain metastases indication and determine the best path forward". He added: "Beyond this indication, the clinical development with Xcytrin continues on multiple fronts".
The setback may also offer an opportunity for Allos Therapeutics' chemo/radio-sensitizer, efaproxiral sodium, which is currently awaiting approval for brain metastases in breast cancer patients.
