Posted by Michael Wonder on 02 May 2017
AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer
1 May 2017 - Approval granted regardless of PD-L1 status, based on tumour response rate and duration of response.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US FDA has granted accelerated approval to Imfinzi (durvalumab).
Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma 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.
Imfinzi is approved under the FDA’s accelerated approval pathway, based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
