Orphan Drug Approved to Treat Rare Cancer

December 31, 2006

Alimta (pemetrexed disodium) from Eli Lilly andCompany has received FDA approval for treatmentof malignant pleural mesothelioma. This orphan drug wasapproved under the FDA’s accelerated program for drugsthat treat cancer or life-threatening disease.

Alimta (pemetrexed disodium) from Eli Lilly andCompany has received FDA approval for treatmentof malignant pleural mesothelioma. This orphan drug wasapproved under the FDA's accelerated program for drugsthat treat cancer or life-threatening disease.Alimta is used in conjunction with cisplatin. In a randomizedtrial of 456 patients, combination therapy withthese 2 agents was associated with a 30% increase in overallsurvival compared with cisplatin alone. Common sideeffects include fatigue, neutropenia, leukopenia, dyspnea,nausea, and vomiting. Pretreatment with a corticosteroiddecreases the incidence of rash associated with the drug.Intramuscular injections of vitamin B12 and daily folic acidsupplements reduce the incidence and severity of hematologicand nonhematologic toxicities in patients who receiveAlimta.