Eli Lilly and Company announced that it has submitted an application with the European Medicines Agency (EMEA) for centralised review of ALIMTA(R) (pemetrexed for injection), in combination with cisplatin, for the first-line treatment of advanced non-small cell lung cancer (NSCLC).
ALIMTA is currently indicated in more than 85 countries as a second-line, single agent for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy, and is also indicated, in combination with cisplatin, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is unresectable or who are otherwise not candidates for curative surgery.
The EMEA submission is based on a study which evaluated ALIMTA plus cisplatin versus GEMZAR(R) (gemcitabine HCl for injection) plus cisplatin. The study met its primary endpoint of non-inferiority relative to overall survival in a first-line NSCLC setting.
“As non-small cell lung cancer is the leading cause of cancer death worldwide, it is important that doctors have a range of treatments for this devastating illness,” said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. “In this clinical study, ALIMTA plus cisplatin demonstrated similar efficacy to GEMZAR plus cisplatin, a widely used regimen for first-line NSCLC, while providing a more favorable toxicity profile and greater convenience. We look forward to the outcome of the EMEA review.”
In September 20, 200704, the EMEA approved ALIMTA as a single agent, second-line treatment for patients suffering from advanced NSCLC, as well as in combination with cisplatin for the treatment of patients with MPM.
In the U.S., ALIMTA was approved by the FDA as a second-line therapy for locally advanced or metastatic NSCLC in August 2004, as well as in combination with cisplatin as a first-line treatment for MPM in February 2004.