Eli Lilly Mesothelioma Drug Approved by the FDA

Alimta, a new first-line drug to treat non-squamous mesothelioma , has been approved by the United States Food and Drug Administration. Its approval is based upon its combination with cisplatin to aid those with locally advanced, metastatic non-small cell lung cancer (NSCLC). Those with squamous non-small cell forms of lung cancer do not have FDA approval to take the drug, but the majority of new lung cancer cases are NSCLC. Use of Alimta as a first line treatment of non-squamous, advanced NSCLC is the third use for the drug to receive U.S. FDA approval. It has been used since 2004 in conjunction with cisplatin for patients with unresectable malignant pleural mesothelioma . In 2004, Alimta was also approved in the US for use as a single-agent for second-line advanced or metastatic NSCLC patients. This has been changed by the FDA to be only for those with non-squamous forms of lung cancer.

A phase III trial resulted in the FDA’s approval for the new use of Alimta. The trial compared the use of combining Alimta with cisplatin against a combination of Gemzar with cisplatin (GC). Results of the study showed an increase in survival rates by one month in those with non-squamous NSCLC cancer against the Gemzar combination. In the group with squamous NSCLC, the survival rates were better by one month with the Gemzar and cisplatin. Patients using the Alimta-cisplatin combination showed fewer toxins in their blood, required fewer blood transfusions, and lowered the use of growth factors when compared to Cisplatin-cisplatin. Common side effects in those taking the Alimta-cisplatin regime included: vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. This new approval adds to the ever-growing list of available treatments for many malignant and often deadly forms of cancer including pleural mesothelioma.