FDA Grants Priority Review to AstraZeneca's sBLA for LS-SCLC Treatment

AstraZeneca has received priority review status from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Imfinzi, aimed at treating limited-stage small cell lung cancer (LS-SCLC). A regulatory decision regarding the therapy is anticipated by the fourth quarter of this year, following the guidelines of the Prescription Drug User Fee Act.

This application is bolstered by data obtained from the Phase III ADRIATIC clinical trial, which involved LS-SCLC patients whose disease remained stable after undergoing platinum-based concurrent chemoradiotherapy. According to the trial outcomes, the use of Imfinzi reduced the mortality risk by 27% when compared to a placebo. Furthermore, patients receiving Imfinzi experienced a significantly longer estimated median overall survival (OS) of 55.9 months, in contrast to the 33.4 months observed in the placebo group.

Additionally, the clinical trial revealed that 57% of patients treated with Imfinzi were still alive three years post-treatment, compared to 48% in the placebo group. Imfinzi also demonstrated a 24% reduction in the risk of disease progression or death, with a median progression-free survival of 16.6 months, versus 9.2 months for the placebo.

Imfinzi maintains a generally manageable safety profile, with no new safety concerns identified during the trial. The FDA had previously granted Imfinzi breakthrough therapy designation for treating LS-SCLC, underscoring the potential impact of this therapy in improving patient outcomes.

Susan Galbraith, AstraZeneca’s Oncology R&D executive vice-president, remarked on the Priority Review, highlighting the transformative potential of Imfinzi as the first and only immunotherapy to show a survival benefit in the treatment of LS-SCLC. She emphasized the urgent necessity for new treatment options that enhance the standard of care, which has remained unchanged for four decades, and expressed eagerness to collaborate with the FDA to make Imfinzi available to patients promptly.

In a related development, AstraZeneca completed the acquisition of Amolyt Pharma in July this year. Amolyt Pharma specializes in treatments for rare endocrine diseases. The acquisition involved a payment of $1.05 billion for all outstanding shares of Amolyt Pharma, free from cash and debt. This transaction included an upfront payment of $800 million, with an additional $250 million contingent upon achieving a specific regulatory milestone.