EFN

Pharmaceutical giant Eli Lilly and Co. announced Monday that the Food and Drug Administration have okayed a new use for its cancer treatment Alimta.

Alimta, which hinders the required absorption by certain tumors of B-vitamin folate, is newly approved for people whose tumor has shrunk or whose cancer has stabilized after chemotherapy.

The findings of the worldwide, multi-center double-blind clinical test were presented in Orlando by Chandra Belani, M.D., Miriam Beckner distinguished professor of medicine and deputy director of Penn State Cancer Institute at Penn State Milton S. Hershey Medical Center.

NSCLC is the most common form of lung cancer, resulting in more than 180 thousand new cases annually in the United States.

Generally patients with advanced, or metastatic, lung cancer that has spread to other parts of the body, are treated with four to six rounds of chemotherapy, and then treatment is stopped in patients whose tumors either stop growing or shrink.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

The idea of maintenance therapy in NSCLC is new. Maintenance therapy is treatment given after initial chemotherapy but before new tumor growth. And while pathologists routinely determine the cancer’s histology, or tissue type, the use of this information to tailor therapy for potentially better outcomes is also new.

Alimta was first approved in 2004 for the treatment of patients with mesothelioma, a cancer often associated to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.