Eli Lilly and Company — Alimta EMA EPAR variation assessment report (EMEA/H/C/000564, 2004)

Report summary

This report summarizes a variation application for Alimta (pemetrexed) to broaden its maintenance treatment indication for non-small cell lung cancer (NSCLC) to all patients post-first-line platinum-based chemotherapy. The application is based on the Phase III PARAMOUNT study, which compared pemetrexed plus best supportive care to placebo in NSCLC patients who had not progressed after pemetrexed and cisplatin induction. The study's primary endpoint was Progression-Free Survival (PFS), with Overall Survival (OS) and Objective Response Rate (RR) as secondary endpoints. Efficacy data includes investigator and independently assessed PFS, tumor response rates, and preliminary OS. Safety data covers deaths during induction, dose modifications, serious adverse events, and identifies pulmonary embolism as a new adverse drug reaction.

Key findings — cited to the page