FDA Approves AstraZeneca’s Imfinzi and Imjudo for Stage 4 NSCLC

The FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with stage 4 nonsmall-cell lung cancer (NSCLC).

Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. Imjudo is also a monoclonal antibody, but it fosters cancer cell death.

The approval was based on a phase 3 clinical trial where the results showed that an estimated 33 percent of patients were alive at two years versus 22 percent for chemotherapy. Trial treatment was a limited course of five cycles of Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy.

Regulatory applications for this indication are currently under review in Europe, Japan and several other countries, the company said.