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The U.S. Food and Drug administration (FDA) has expanded the approval of the chemotherapy drug Alimta® (pemetrexed) to include maintenance therapy for locally advanced or metastatic, nonsquamous, non-small cell lung cancer.[1]

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Subtypes of NSCLC include adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. “Nonsquamous” NSCLC refers to all types of NSCLC except for squamous cell carcinoma.

Treatment of advanced NSCLC often involves chemotherapy. Currently available combination chemotherapy regimens can improve the duration of survival as well as quality of life, but researchers continue to search for ways to improve outcomes for patients with this disease.

Maintenance therapy refers to treatment that is given after initial treatment but before cancer progression. Alimta is the first drug to be approved as maintenance therapy for advanced NSCLC.

The efficacy of Alimta as maintenance therapy was assessed in a Phase III clinical trial.[2] The study enrolled more than 600 patients with Stage IIIB or IV NSCLC that had not progressed after four cycles of platinum-based chemotherapy. In addition to standard medical care, some patients were given Alimta maintenance therapy and other patients were given a placebo. Patients in the Alimta group lived longer than patients in the placebo group. The benefit of Alimta was only observed among patients with nonsquamous NSCLC. Among these patients, median overall survival was 15.5 months in the Alimta group compared with 10.3 months in the placebo group.

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Based on these results, the FDA expanded the approval of Alimta to include use as maintenance therapy in patients with locally advanced or metastatic, nonsquamous, NSCLC that has not progressed after four cycles of platinum-based first-line chemotherapy.

Alimta was first approved in 2004 for the treatment of mesothelioma (a cancer that is often linked to asbestos exposure). The drug was later approved for first- and second-line treatment of advanced NSCLC. Alimta is not indicated for the treatment of squamous cell NSCLC.


[1] FDA News Release. FDA approves first maintenance drug therapy for advanced lung cancer. Available at: Accessed July 6, 2009.

[2] Belani CP, Brodowicz T, Ciuleanu T et al. Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC). Presented at the 2009 annual meeting of the American Society of Clinical Oncology. May 29-June 2, 2009. Orlando, FL. Abstract CRA8000.

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