The US Food and Drug Administration (FDA) has rejected Pharmacyclics Inc's new drug application (NDA) for Xcytrin (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. The NDA for use of Xcytrin in combination with whole brain radiation therapy (WBRT) was filed with the FDA in April 2007.
The federal agency sent a non approvable letter for Xcytrin demanding the company to perform further studies so as to prove the drug effective.
According to the National Cancer Institute, over 200,000 patients will be diagnosed with lung cancer this year in the US Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50 per cent of lung cancer patients.
Pharmacyclics recently completed patient enrolment in three phase II trials evaluating Xcytrin in patients with advanced relapsed NSCLC. These multi-centre trials will evaluate Xcytrin as a single agent, in combination with Taxotere (docetaxel), and in combination with Alimta (pemetrexed). Data from these trials is expected in the first half of 2008.
"We are disappointed that brain metastases patients with limited options and serious neurologic problems will not have access to Xcytrin, which we believe has shown important clinical activity in this indication," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "We continue to believe that Xcytrin is a novel active cancer drug and we will seek a corporate partner to help support future development. In the meantime, we are also advancing our expanding and versatile pipeline of product candidates."
Xcytrin's novel mechanism enables it to selectively concentrate in tumours and induce apoptosis (programmed cell death). Its multifunctional mode of action, including its magnetic resonance imaging detectability and its non-overlapping toxicity, make Xcytrin an appealing agent to use in combination with standard chemotherapy regimens, potentially across a broad range of cancers.
In addition to Xcytrin, the company's other product candidates include a histone deacetylase (HDAC) inhibitor in a phase I/II trial, and a factor VIIa inhibitor and a Bruton's tyrosine kinase (BTK) inhibitor in pre-clinical testing for cancer and autoimmune diseases.
Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms.
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