SY15-2 - Challenges in Safety Management for New Anticancer Drug: Perspectives from a Pharmaceutical Company

Abstract

ABSTRACT When developing new drugs, its efficacy and safety data are accumulated throughout the progress of the development phases. Pharmaceutical companies are intrinsically making efforts to examine information related to efficacy and safety of drugs obtained from the clinical trials, reflect them in the package insert and materials for proper use, and provide them to HCPs. However, it was also pointed out that post marketing risk management is conducted only after safety issues occur. In April 2011, risk management plan (RMP) guidance (draft) was released as a guidance when pharmaceutical companies consider further surveillances and studies regarding the safety of the product and additional actions to mitigate risks in the time of new drug application review and the post-marketing phase, and the Ministry of Health, Labour and Welfare (MHLW) called for 'Public Comments' (voice of the people) on its website. In European countries, RMP, which is a mandatory requirement when applying new drugs, plays focal role in risk management and is expected to contribute enhancement of systematic risk management. Before RMP guidance (Draft) announced last year, Eli Lilly Japan, K.K., started to plan its RMP activities in accordance with EU RMP for continuous actions to evaluate and mitigate risks. As an example I would like to explain about an anticancer drug, Alimita (pemetrexed) RMP, which was constructed when approved for malignant pleural mesothelioma (MPM) in 2007 and additionally for non-small cell lung cancer (NSCLC) in 2009, to introduce pharmaceutical companies' approach to implement Risk Management and its proper use for the launch of newly approved anticancer drugs.