FDA Approves AstraZeneca's Imfinzi For Limited-Stage Small Cell Lung Cancer

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(RTTNews) - The U.S. Food and Drug Administration has approved AstraZeneca plc's (AZN, AZN.L) Imfinzi, also known as durvalumab, for the treatment of adults with limited-stage small cell lung cancer. This approval is specifically for patients who have not shown disease progression after receiving concurrent platinum-based chemotherapy and radiation therapy.

The FDA said that efficacy was evaluated in ADRIATIC, a randomized, double-blind, placebo-controlled trial in 730 patients with limited-stage small cell lung cancer 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.

Durvalumab demonstrated a statistically significant overall survival improvement compared to placebo with a hazard ratio (HR) of 0.73. The median overall survival was 55.9 months in the durvalumab arm and 33.4 months in the placebo arm. Durvalumab also demonstrated a statistically significant progression-free survival improvement compared to placebo with HR of 0.76. The median progression-free survival was 16.6 months and 9.2 months in the durvalumab and placebo arms, respectively.

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

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