AstraZeneca's Imfinzi clears latest FDA regulatory hurdle

AstraZeneca and its global biologics research and development arm MedImmune announced on Tuesday that 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 (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

The FTSE 100 drugmaker said the FDA has granted Imfinzi ‘priority review’ status.

It said the FDA’s sBLA submission acceptance was an “important milestone” for Imfinzi in a disease state where patients needed better treatment options and outcomes.

Currently, AstraZeneca said the standard of care for patients with the earlier stage of lung disease was active monitoring following concurrent chemoradiation.

“The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial,” AstraZeneca’s board explained.

“The trial continues to evaluate overall survival (OS), its other primary endpoint.”

AstraZeneca added that on 28 September, the US NCCN Clinical Practice Guidelines in Oncology were updated to include Imfinzi 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.

That indication was not yet FDA-approved, however.