Eli Lilly and Company Alimta(pemetrexed for injection)has received FDA approval for new use in the continuation maintenance setting for advanced or metastatic nonsquamous non-small cell lung cancer(NS NSCLC).
The approval was based on Phase III data that showed progression-free and overall survival benefits when continuation maintenance setting was carried in the patients.
With the approval,patients suffering from NS NSCLC who receive Alimta plus cisplatin as first-line therapy can continue with Alimta in the maintenance setting.
Lilly Oncology product development and medical affairs vice president Richard Gaynor said the approval provides patients and physicians with a new procedure that has demonstrated an improvement in overall survival.
"A survival benefit was previously established for ALIMTA for the first-line treatment of advanced nonsquamous non-small cell lung cancer in combination with cisplatin,and now as a single-agent for continuation maintenance treatment,"Gaynorb added.
"This is the first study to show a survival advantage for continuation maintenance,and it reinforces the role of ALIMTA in treating patients with advanced nonsquamous NSCLC."
Alimta is specific for the maintenance treatment of locally advanced or metastatic NS NSCLC patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
The frequent dose-limiting toxicity with Alimta therapy is Myelosuppression.
