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FDA Approves First Maintenance Rx for Advanced Lung Cancer


2009-07-06
FDA Approves First Maintenance Rx for Advanced Lung Cancer

FDA批准晚期肺癌的首个维持治疗处方

Elsevier Global Medical News. 2009 Jul 6, E Mechcatie



Pemetrexed, a folate analogue metabolic inhibitor, has been approved as the first maintenance treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer, the Food and Drug Administration announced in a statement on July 6.



"This drug represents a new approach in the treatment of advanced non-small cell lung cancer," Dr. Richard Pazdur, director of the FDA's office of oncology drug products, said in the statement. "Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four to six chemotherapy cycles," he added.



Dr. Pazdur referred to a study that showed an advantage in overall survival in certain patients who received maintenance therapy with pemetrexed.



Maintenance therapy with pemetrexed was compared with placebo in a multicenter study of 663 patients with stage IIIb/IV non-small cell lung cancer, whose disease had not progressed after four cycles of platinum-based chemotherapy.



Among those with nonsquamous small cell lung cancer treated with pemetrexed (481 patients), overall survival was a median of 15.5 months, vs. 10.3 months among those who received a placebo. In this group, progression-free survival was a median of 4.4 months among those on pemetrexed, compared with 1.8 months among those on placebo, according to the prescribing information.



No benefit was seen among patients with predominantly squamous cell cancer. The drug is not approved for patients with squamous cell non-small cell lung cancer.



Dr. Chandra P. Belani of Penn State Cancer Institute in Hershey, Pa., reported the pemetrexed findings at this year's annual meeting of the American Society of Clinical Oncology.



Pemetrexed, marketed as Alimta by Eli Lilly & Co., was approved in September 2008 for treating locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin, or after previous chemotherapy. It is administered intravenously. Pemetrexed was initially approved in 2004 for treating patients with mesothelioma.



To view a video interview of Dr. Belani, go to www.youtube.com/watch?v=9S_-jhW_FoE.



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