EC approves Lilly's ALIMTA as continuation maintenance therapy for NSCLC

Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted approval for the use of ALIMTA® (pemetrexed for injection) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer (NSCLC). The approval is based on clinical trial results showing an improvement in progression-free survival, as well as a preliminary analysis showing a strong trend toward better overall survival, for NSCLC patients treated first with ALIMTA plus cisplatin and then continue treatment with ALIMTA alone in the maintenance setting.

ALIMTA is the first chemotherapy agent to be approved in Europe for continuation maintenance therapy. In this setting, patients whose disease has not progressed immediately following first-line treatment with ALIMTA plus cisplatin can continue maintenance treatment with ALIMTA alone and achieve additional benefit.

Continuation maintenance therapy with ALIMTA is specifically tailored to benefit the group of patients with a particular type of NSCLC, called nonsquamous, and who have shown a positive response or disease stabilization after treatment with first-line ALIMTA plus cisplatin. Although other maintenance regimens are currently available for NSCLC, they involve using different medicines in the maintenance phase of treatment than were used in the first-line setting.

"This latest approval for ALIMTA represents an important advance in the treatment of advanced lung cancer," said Allen Melemed, M.D., M.B.A., senior medical director with Lilly Oncology. "Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient. With ALIMTA continuation maintenance therapy, patients with lung cancer who have already benefited from first-line treatment will now have the option to continue treatment with ALIMTA, with the goal of a better clinical outcome."