Fast track designation would have allowed for a rolling submission of the biologics license application (BLA), but Genentech will now have to submit a completed version of the application in December.
In addition, the company is in discussion with the FDA regarding plans to initiate a phase IIIb clinical study of Lucentis. The study is anticipated to begin before the end of 2005. One-year phase III data from a study presented at the annual meeting of the American Society of Retina Specialists in July showed Lucentis improved vision in patients with wet age-related macular degeneration (AMD).
“We recognize the significant unmet medical needs of those with wet AMD and hope to make Lucentis available to patients by seeking FDA approval as quickly as possible,” said Dr Hal Barron, Genentech senior vice president of development and chief medical officer. “We are encouraged by the magnitude of the benefit observed in the one-year Lucentis MARINA data and are excited about this new phase IIIb trial, which will help provide more information about the safety profile of Lucentis and the treatment regimen for this chronic disease.”
Patients in the new study will receive Lucentis once a month for three months with criteria-based re-treatment options. Genentech anticipates that patients with wet AMD who have not received prior treatment for their disease or who continue to have active disease despite treatment with FDA-approved therapies may be eligible to enroll in the study. The study will be conducted at more than 100 sites in the US and enroll approximately 5,000 patients.