Advisory panel provides FDA a platform to discuss lentiviral cancer risk

FDA’s Cellular, Tissue and Gene Therapy Advisory Committee is set to meet this week to discuss a pair of gene therapy BLAs from bluebird bio that could have big impacts on the company’s future, and on broader development of lentiviral vector-based gene therapies.

The outcome of the meetings, and the comments that FDA representatives make throughout, will inform gene therapy developers on the agency’s tolerance for oncogenesis risk from lentiviral vectors — a risk that all lentiviral vectors carry...