EMEA has agreed to an oral explanation in support of the Cell Therapeutics’ OPAXIO Marketing Authorization Application (MAA) in September 2009. It extended the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on approval until Q4, 2009.
In April 2008, EMEA accepted to review the MAA for OPAXIO. It was for first-line treatment of patients with advanced non-small cell lung cancer with performance status 2, based on a non-inferior survival and improved side effect profile. The previous meeting with EMEA on OPAXIO did not occur due to conflicts in regulatory schedule, as CTI focused on completing the pixantrone New Drug Application (NDA) submission in June 2009.
James Bianco, CEO of Cell Therapeutics, said: We are pleased that the EMEA has agreed to an in person oral explanation in September allowing the company and its lung cancer experts adequate time to prepare a thorough review for the Co-rapporteurs in support of our MAA for OPAXIO in non-small cell lung cancer. The fourth quarter is shaping up to be a pivotal period for the Company.