USFDA NDA for Xcytrin® Injection for Lung Cancer Brain Metastases Treatment, Submitted by Pharmacyclics
Pharmacyclics, Inc. (Nasdaq: PCYC) has recently filed a New Drug Application (NDA) to the USFDA for its Xcytrin® (motexafin gadolinium) Injection, seeking approval to market the drug for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases.
According to Richard A. Miller, MD, President and CEO of Pharmacyclics:
"We are very eager to work with the Agency to complete a thorough and fair review of the extensive data in our NDA.
We and our investigators, outside experts and patient advocates believe our data support the efficacy and safety of Xcytrin for the treatment of brain metastases for patients with non-small cell lung cancer and justify a comprehensive review by the Agency.
We believe it is in the best interests of patients to do everything we can to make this drug available for patients with this terrible disease for which few treatment options exist."
Xcytrin® is an anti-cancer agent whose novel mechanism of action is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death) and has the potential for use in a broad range of cancers.
Find more details from the full report.
Comment Preview