In its effort to seek approval for marketing of Xcytrin for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., cancer that has spread to the brain from another part of the body), Pharmacyclics, Inc. (Nasdaq: PCYC) has submitted a New Drug Application (NDA) for Xcytrin(R) (motexafin gadolinium) Injection to the USFDA.
According to Richard A. Miller, M.D., president and CEO of Pharmacyclics:
"The clinical development program with Xcytrin continues on multiple fronts. In addition to the completed trials in brain metastases, which form the basis of our NDA submission, several other 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."
Pharmacyclics' NDA data package included efficacy and tolerability data from two Phase 3 randomized, controlled trials involving 805 patients, which compared the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin.
Read the full press release.
[Photo Credit: www.gammaknifecenter.com]
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