Eli Lilly and Co. announced on Monday that the Food and Drug Administration has approved the use of Alimita as a first-line treatment for patients with locally advanced and metastasized non-small cell lung cancer, but only for those with non-squamous histology. The drug should be used in combination with Cisplatin and only to patients that already had received a form of chemotherapy.

In February 2004, the Food and Drug Administration approved the drug for treatment of malignant pleural Mesothelioma, a type of tumor of the lining of the lung, one of the most common types of lung cancer, usually linked to extensive asbestos exposure. More than 180,000 new cases are registered in the U.S. alone each year.

The FDA’s decision came after a much-debated clinical test. 1725 patients were administered two types of treatment. One was Alimita plus Cisplatin and the other was Gemzar in combination with Cisplatin. Patients treated with the Alimita regimen had less hematologic toxicity, fewer blood transfusions and decreased use of growth factors compared to those treated with the Gemzar regimen.

The most common adverse reactions for the Eli Lilly and Co. drug in combination with Cisplatin included vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis, thrombocytopenia and constipation.

Now that Alimita received the FDA approval, more and more patients will be treated with the drug, but some measures are to be taken. The patients are required to be on folic acid and vitamin B12 supplementation when they are on pemetrexed therapy, in order to reduce the frequency of adverse events and it is also recommended for patients to be on a steroid the day prior, day of, and day after taking the drug, in order to avoid skin rashes.