EU lung cancer approval for Alimta

Alimta (pemetrexed for injection) has become the first agent approved in Europe as maintenance therapy for advanced, nonsquamous non-small cell lung cancer.

The European Commission granted approval for the use of Alimta as a monotherapy for maintenance treatment of patients with other than predominantly squamous cell histology in locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose disease has not progressed immediately following platinum-based chemotherapy.

The approval is based on data that showed pemetrexed improved overall survival in other than predominantly squamous NSCLC patients in the maintenance setting.

Pemetrexed is a chemotherapy agent currently approved for first-line treatment of advanced, other than predominantly squamous NSCLC in combination with a platinum-based chemotherapy, and as a single agent in the second-line setting for advanced, other than predominantly squamous NSCLC patients with recurrent disease.

The use of maintenance therapy in this setting represents a change to treatment, as traditionally, patients who respond to first-line chemotherapy were monitored until the disease recurred and then treated with a second-line regimen.

“The idea behind Alimta as maintenance therapy for nonsquamous, non-small cell lung cancer is to treat patients immediately following their initial course of therapy, in an effort to prolong survival,” said Richard Gaynor, Vice President, Cancer Research and Global Oncology Platform Leader at Eli Lilly.

“The study that led to this approval was the first that showed improved overall survival in the maintenance setting for NSCLC. This was also the third trial to show the benefit of tailoring ALIMTA treatment to the nonsquamous NSCLC patient population.”