The United States Food and Drug Administration (FDA) has accepted the new drug application (NDA) submitted for Pharmacyclics’ new agent Xcytrin (motexafin gadolinium). Pharmacyclics is seeking approval for the use of Xcytrin in combination with radiation therapy for the treatment of patients with non-small cell lung cancer (NSCLC) and brain metastases.
The NDA was submitted despite the fact that Xcytrin did not meet its primary endpoint which was overall survival in its two randomized trials. However, Xcytrin did demonstrate an improvement in neurologic progression among patients with NSCLC. The FDA had previously refused to accept the NDA for Xcytrin because of the failure to meet the primary endpoint of survival. Despite this, Pharmacyclics filed its request for review.
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