AstraZeneca's durvalumab (Imfinzi) gets sped-up FDA process
FDA has agreed to speed up the process required for development and regulatory review of AstraZeneca's new lung cancer drug durvalumab (Imfinzi).
FDA has agreed to speed up the process required for development and regulatory review of AstraZeneca's new lung cancer drug durvalumab (Imfinzi). AstraZeneca and MedImmune, its global biologics research and development arm, said Monday that the agency has granted Breakthrough Therapy Designation for durvalumab for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.