AstraZeneca and MedImmune announced that the Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
Imfinzi, a programmed death-ligand 1 (PD-L1) blocking antibody, is already indicated to treat locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The FDA’s approval was supported by positive progression-free survival (PFS) data from the Phase 3 PACIFIC trial (N=713) which compared Imfinzi to placebo. In the study, treatment with Imfinzi showed an improvement in median PFS of 11.2 months vs placebo, which translates to a 48% reduction in relative risk of progression or death vs placebo in all patients regardless of PD-L1 status (hazard ratio [HR] 0.52, 95% CI: 0.42, 0.65; P<0.0001). The ongoing trial is also evaluating overall survival (OS) in patients with unresectable Stage III NSCLC.
Cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash were the most common adverse reactions reported with Imfinzi.
“This is the first treatment approved for Stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients with Stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”
Imfinzi is available as a 50mg/mL strength solution for intravenous (IV) infusion in single-dose vials.
For more information call (800) 237-8898 or visit Imfinzi.com.