Immunomedics, a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other diseases, has received a fast-track designation from the FDA for its yttrium-90-labeled hPAM4 for the treatment of pancreatic cancer.
Under fast-track programs, compounds selected must demonstrate the potential to address unmet medical needs. The designation allows for close and frequent interaction with the agency. A designated fast-track drug may also be considered for priority review with a shortened review time, rolling submission, and accelerated approval, if applicable. The designation does not, however, guarantee approval or expedited approval of any application for the product.
"The current Phase Ib fractionated dose-escalating study of hPAM4 in combination with gemcitabine is enrolling patients as fast as the protocol permits and we look forward to closely working with FDA for the development and regulatory review of this important new antibody, a potential first-in-class radioimmunotherapeutic agent for pancreatic cancer," remarked Cynthia L. Sullivan, president and CEO of the Morris Plains, N.J.-based Immunomedics.