Published: 19 October 2012
Washington-the FDA has the indication for Pemetrexed (Alimta) injection include extended maintenance therapy in combination with cisplatin for non-small cell lung cancer (NSCLC).
The FDA decision was based on data from a phase III study of 939 patients with advanced NSCLC reported June, 2012 at the meeting of the American Society of Clinical Oncology in the beginning, built its effectiveness in the maintenance therapy.
In this patients received study 500 mg/m2 of Pemetrexed injection on 21-day cycles with 75 mg / m2 of cisplatin, as well as vitamin B12 , folic acid and dexamethasone. The 539 patients whose Krankheit randomly while the dual treatment segment two to one for Pemetrexed maintenance or placebo were next. Both study arms received best supportive therapy in addition to medication or placebo treatment.
Compared to placebo, Pemetrexed treatment use was modest --44% of Pemetrexed treated patients achieved a complete or partial response of induction therapy, compared to 42% of patients, while 53% of patients, the drug therapy and placebo had stable disease after license or drug abuse treatment.
But the drug treatment had patients, a significantly lower risk of death (CI 0.64 to 0.96, P= 0.02 HR 0.78, 95%), and median progression-free survival for patients, the Pemetrexed was 4.1 months to 2.8 months with placebo.
Side effects for Pemetrexed as maintenance treatment contain during the trials, anemia, neutropenia, fatigue, nausea, vomiting, mucositis, stomatitis, and edema.
The drug was initially approved in 2004 as a combination therapy with cisplatin for malignant pleural mesothelioma, where disease was unresectable or curative operation not possible and a second-line treatment for locally advanced metastatic NSCLC after prior chemotherapy treatment.
Pemetrexed was approved in 2008 as a first-line treatment for locally advanced or metastatic NSCLC patients histologically. In 2009 the drug received approval as a maintenance therapy for locally advanced or metastatic NSCLC patients histologically after four cycles of platinum based chemotherapy without progression of the disease.
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