AstraZeneca and MedImmune announced the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for IMFINZI (durvalumab) 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. The FDA has granted IMFINZI Priority Review status.
The FDA sBLA submission acceptance is an important milestone for IMFINZI in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for these patients with locally advanced (Stage III) lung cancer is active monitoring following definitive chemoradiation.
The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint. Detailed results of the PACIFIC trial, including additional safety information, were published online in the New England Journal of Medicine.
On September 28, 2017, the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) were updated to include durvalumab for the treatment of patients with locally advanced, unresectable NSCLC with no disease progression after two or more cycles of definitive chemoradiation, based on the data from the PACIFIC Phase III trial. This indication is not yet FDA-approved.
IMFINZI has already received accelerated approval in the US 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.