FDA grants Priority Review to durvalumab for limited-stage small cell lung cancer ( LS-SCLC) after concurrent chemoradiotherapy
The FDA has granted priority review to the supplemental biologics license application (sBLA) seeking the approval of durvalumab (Imfinzi) for the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy
Additionally, the regulatory agency awarded breakthrough therapy designation to durvalumab for this indication.
The sBLA is supported by data from the phase III ADRIATIC trial (NCT03703297). Findings presented at the 2024 ASCO Annual Meeting showed that at a median follow-up of 37.2 months (range, 0.1-60.9), evaluable patients treated with durvalumab (n = 264) experienced a median overall survival (OS) of 55.9 months (95% CI, 37.3-not evaluable) vs 33.4 months (95% CI, 25.5-39.9) for those given placebo (n = 266; HR, 0.73; 95% CI, 0.57-0.93; P = .0104).
Furthermore, at a median follow-up of 27.6 months (range, 0.0-55.8), durvalumab elicited a median progression-free survival (PFS) of 16.6 months (95% CI, 10.2-28.2) compared with 9.2 months (95% CI, 7.4-12.9) for placebo (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).
“This priority review reinforces the potential of [durvalumab] to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in LS-SCLC,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, stated in a news release.1 “There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in 40 years, and we look forward to working with the FDA to bring [durvalumab] to patients as quickly as possible.”
See- Spigel DR, Cheng Y, Cho BC, et al." ADRIATIC: durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC)". J Clin Oncol. 2024;42(suppl 17):LBA5. doi:10.1200/JCO.2024.42.17_suppl.LBA5.
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