IMFINZI™ (Durvalumab) Granted Breakthrough Therapy Designation by US FDA for Patients with Locally Advanced Unresectable Non-Small Cell Lung Cancer

AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for IMFINZI™ (durvalumab), an anti-PD-L1 monoclonal antibody, being investigated for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

AstraZeneca’s IMFINZI™ (Durvalumab) Receives US FDA Accelerated Approval For Previously Treated Patients With Advanced Bladder Cancer

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI™ (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.