The European Commission has granted approval for Eli Lilly and Company’s Alimta (pemetrexed for injection) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced non-squamous 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."

Approval of Alimta continuation maintenance was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study examined whether Alimta continuation maintenance therapy improves progression-free survival, as well as overall survival, after Alimta -cisplatin induction therapy in patients with advanced nonsquamous NSCLC. The study met its primary endpoint of progression-free survival, and a preliminary analysis has shown a strong trend toward positive overall survival.  

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

Alimta is also approved, in combination with cisplatin, in both the EU and US for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.