INDIANAPOLIS (dpa-AFX) - Eli Lilly & Co. (LLY) announced that patients may receive Alimta (pemetrexed for injection) as a maintenance therapy following first-line Alimta plus cisplatin for locally advanced or metastatic nonsquamous non-small cell lung cancer or NS NSCLC.
The company said that FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients.
The company said that appropriate patients can now start with ALIMTA plus cisplatin and continue with Alimta in the maintenance setting in advanced or metastatic NS NSCLC.
Alimta is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Alimta is not indicated for patients with squamous-cell NSCLC. Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.
The approval was based on results from PARAMOUNT, a global, multicenter, double-blind Phase III trial.
The company said that the Final results of the PARAMOUNT trial demonstrated a statistically significant 22 percent reduction in the risk of death (HR=0.78; 95% CI: 0.64-0.96; p=0.02) with ALIMTA, compared to placebo. This reduction in the risk of death resulted in an improved median overall survival from the time patients were randomized of 13.9 months median for patients receiving ALIMTA, compared to 11.0 months median for patients on the placebo arm.
Common adverse reactions (all grades) with ALIMTA as a single agent versus placebo, respectively, were anemia (15% vs 4.8%); neutropenia (9% vs 0.6%); fatigue (18% vs 11%); nausea (12% vs 2.4%); vomiting (6% vs 1.8%); mucositis/stomatitis (5% vs 2.4%); edema (5% vs 3.6%).
In 2008, ALIMTA, in combination with cisplatin, was approved as a first-line treatment for locally advanced or metastatic NSCLC for patients with nonsquamous histology.
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