Merck KGaA and Biomira Inc announced that the US Food & Drug Administration (FDA) has granted fast-track status to the investigation of L-BLP25 Liposome Vaccine for its proposed use in the treatment of non-small cell lung cancer (NSCLC).
Biomira submitted a fast-track application to the FDA, which included encouraging results from a controlled, randomized phase IIb study in Stage IIIB and IV NSCLC patients. Results from the phase IIb study will be presented at the European Society of Medical Oncology Meeting (ESMO) to be held in Vienna, Austria, on November 1. Plans are also underway for a large, multi-center Phase III study, release from Merck said.
Under terms of a March 2001 agreement, Merck KGaA and Biomira will jointly market L-BLP25 in the US. Merck KGaA will market the product through its US affiliate, EMD Pharmaceuticals. Merck KGaA will have sole development and marketing rights in the rest of the world with the exception of Canada, Israel and the Palestinian Autonomy Area.
The FDA's fast-track programme is designed to facilitate the development and expedite review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management.