FDA grants Orphan Drug Designation to Imfinzi for SCLC

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Imfinzi (durvalumab), a PD-L1 inhibitor for the treatment of patients with extensive-stage small cell lung cancer (SCLC).

The drug is a monoclonal antibody that binds to PD-L1 and blocks the interaction between PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. 

The AstraZeneca Phase III CASPIAN study found positive results for the medication in June. The trial saw the treatment meet its primary endpoints when combined with the standard-of-care medicine, etoposide and platinum-based chemotherapy.

It is the first study to offer the flexibility of combining immunotherapy with different platinum-based regimens in small lung cancer.

José Baselga, Executive Vice President, R&D Oncology, said the company is “eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible.”

Imfinzi is currently approved for unresectable, stage III non-small cell lung cancer (NSCLC) in the US. The company is evaluating the drug in several late-stage programmes for treating stage IV NSCLC. 

The drug is also being tested in the Phase III ADRIATIC assessment following a concurrent chemoradiation therapy for the limited-stage SCLC.