U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Resources for Information | Approved Drugs
  6. FDA approves durvalumab for limited-stage small cell lung cancer
  1. Resources for Information | Approved Drugs

FDA approves durvalumab for limited-stage small cell lung cancer

On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

Full prescribing information for Imfinzi will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in ADRIATIC (NCT03703297), a randomized, double-blind, placebo-controlled trial in 730 patients with LS-SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy. Patients were randomized 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab, or placebo.

The major efficacy outcome measures were overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review for the comparison between durvalumab as a single agent and placebo. Durvalumab demonstrated a statistically significant OS improvement compared to placebo with a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.93; p-value 0.0104). The median OS was 55.9 months (95% CI: 37.3, not reached) in the durvalumab arm and 33.4 months (95% CI: 25.5, 39.9) in the placebo arm. Durvalumab also demonstrated a statistically significant PFS improvement compared to placebo with HR of 0.76 (95% CI: 0.61, 0.95; p-value 0.0161). The median PFS was 16.6 months (95% CI: 10.2, 28.2) and 9.2 months (95% CI: 7.4, 12.9) in the durvalumab and placebo arms, respectively.

The most common adverse reactions (≥20%) were pneumonitis or radiation pneumonitis and fatigue.

The recommended durvalumab dose is 1,500 mg every 4 weeks for patients with a body weight of ≥30 kg and 20 mg/kg every 4 weeks for patients with a body weight of <30 kg until disease progression or unacceptable toxicity or a maximum of 24 months.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic (SMC). The European Medicines Agency (EMA) was an official observer of this review. The application reviews may be ongoing at the other regulatory agencies.

Expedited Programs

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review and breakthrough designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

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 or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

Back to Top