The new drug application will be primarily based on data from the company’s SMART trial, which was conducted at 94 centers in North America, Europe and Australia and enrolled 554 patients with brain metastases from non-small cell lung cancer (NSCLC).
This randomized, controlled phase III trial compared the safety and efficacy of whole brain radiation therapy (WBRT) alone to WBRT plus Xcytrin. The primary endpoint of the study was time to neurologic progression as determined by a blinded events review committee.
Results from the study have not yet been made public but will be presented at the forthcoming annual meeting of the American Society of Clinical Oncology.
Xcytrin was previously granted fast track designation by the FDA for use in the treatment of lung cancer brain metastases. This designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition.
According to the company, the drug’s multifunctional mode of action suggests that it could have potential in the treatment of a broad range of cancers.