This marks the third US indication for Alimta. In 2004, Alimta has received consecutive approvals: first in combination with cisplatin as a treatment for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy treatment.
The Alimta approval in first-line advanced NSCLC for nonsquamous cell histology is based on a Phase III, open-label randomized study (1725 patients) that evaluated Alimta plus cisplatin versus Gemzar plus cisplatin. Based on the same data, the FDA also approved a change to the second-line indication.
Alimta is indicated as a single agent for the treatment of patients with locally-advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy. Alimta is not indicated for treatment of patients with squamous cell non-small cell lung cancer.