ALIMTA receives positive opinion from CHMP

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA® (pemetrexed for injection) as continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Positive opinions from the CHMP are reviewed by the European Commission, which then decides on whether to approve the indication in Europe.

Maintenance therapy is a relatively new concept in lung cancer treatment in which patients start maintenance therapy immediately following their first-line treatments to try to maintain disease control. No chemotherapy is currently approved in the “continuation maintenance” setting, in which one of the same medicines used in first-line treatment is continued as maintenance therapy. Currently approved maintenance therapies in lung cancer use different medicines in the first-line and maintenance phases of treatment.

“Lung cancer is one of the most difficult cancers to treat and new therapy options are much needed,” said Allen Melemed, M.D., M.B.A., Alimta senior medical director with Lilly Oncology. “If approved, ALIMTA would be the first tailored treatment option based on efficacy that can potentially extend lives beginning in first-line treatment and continuing through maintenance in advanced nonsquamous non-small cell lung cancer.”

The CHMP’s opinion was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology Annual Meeting.(1) In this study, patients with advanced nonsquamous NSCLC received initial therapy with four cycles of ALIMTA plus cisplatin. Patients whose disease did not progress continued to the maintenance phase, where progression-free survival was assessed in patients who received ALTIMA plus best supportive care (BSC), compared with those who received placebo plus BSC.

In the EU and U.S., ALIMTA is already approved in the first-line, maintenance and second-line settings for treatment of patients with advanced nonsquamous NSCLC.