On February 16, 2018, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca Inc.) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Approval was based on a planned interim analysis of progression-free survival (PFS) from PACIFIC (NCT02125461), a randomized double-blind, placebo-controlled trial conducted in 713 patients with unresectable, stage III NSCLC. Patients completed concurrent platinum-based chemotherapy and radiation within 42 days prior to study drug initiation and had WHO performance status of 0 or 1. The major efficacy measures were PFS (blinded independent central review per RECIST 1.1) and overall survival (OS). With approximately 81% of planned events for the final analysis, the trial demonstrated a statistically significant improvement in PFS for durvalumab compared to placebo (HR 0.52; 95% CI: 0.42, 0.65; p<0.00010). the="" estimated="" median="" pfs="" was="" 16.8="" months="" for="" patients="" receiving="" durvalumab="" and="" 5.6="" months="" for="" those="" receiving="" placebo.="" survival="" results="" were="" immature="" at="" the="" interim="" pfs="">0.00010).>
The most common adverse reactions (occurring in at least 20% of patients receiving durvalumab in PACIFIC) were cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea and rash.
The recommended dose and schedule for durvalumab for this indication is 10 mg/kg as an intravenous infusion over 60 minutes every two weeks.
Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761069s002lbl.pdf.
FDA granted this application Priority Review and Breakthrough Therapy designations. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
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