FDA Approves AstraZeneca’s Imfinzi for Use Before and After Lung Cancer Surgery

Approval Date:
The FDA approved AstraZeneca's Imfinzi (durvalumab) on August 16, 2024, for use before and after surgery in patients with resectable non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements.

Indication:
Imfinzi is approved for use in combination with platinum-containing chemotherapy before surgery (neoadjuvant) and as a single agent after surgery (adjuvant) for adult patients with resectable NSCLC.

Clinical Trial:
The approval was based on the Phase III AEGEAN trial, which showed a statistically significant and clinically meaningful reduction in the risk of recurrence, progression, or death with the chemoimmunotherapy regimen compared to chemotherapy alone.

Efficacy:
The trial demonstrated a pathologic complete response rate of 17% with durvalumab versus 4.3% with placebo. Event-free survival at 12 months was 73.4% with durvalumab versus 64.5% with placebo.

Dosage:
The recommended dosage for patients weighing more than 30 kg is 1500 mg every 3 weeks before surgery and every 4 weeks afterward. For patients weighing less than 30 kg, the dosage is 20 mg/kg.

Side Effects:
Common adverse reactions included anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash. A small percentage of patients could not undergo surgery due to side effects during neoadjuvant treatment.