September 30, 2008
Lilly Wins FDA Approval for Lung Cancer Drug
Eli Lilly and Company has received approval from the FDA for the use of Alimta in combination with cisplatin, in the first-line treatment of locally-advanced and metastatic non-small cell lung cancer, for patients with nonsquamous histology.
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.