AstraZeneca has received priority review from the US Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for Imfinzi to treat limited-stage small cell lung cancer (LS-SCLC).
A regulatory decision on the approval of the therapy is expected by the fourth quarter of this year, under the Prescription Drug User Fee Act.
The application is supported by data from the Phase III ADRIATIC clinical trial in LS-SCLC patients whose disease did not progress after treatment with platinum-based concurrent chemoradiotherapy.
According to the findings, Imfinzi cut down mortality risk by 27% compared to placebo.
Patients treated with Imfinzi had an estimated median overall survival (OS) of 55.9 months, significantly longer than the 33.4 months observed in the placebo group.
Additionally, 57% of patients on Imfinzi were alive at three years, compared to 48% on placebo.
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The treatment also showed a 24% reduction in the risk of disease progression or death, with a median progression-free survival of 16.6 months for Imfinzi versus 9.2 months for placebo.
AstraZeneca’s Imfinzi has a generally manageable safety profile, with no new safety signals detected during the trial.
The FDA previously granted Imfinzi breakthrough therapy designation for the treatment of LS-SCLC.
AstraZeneca Oncology R&D executive vice-president Susan Galbraith said: “This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer.
“There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in forty years, and we look forward to working with the FDA to bring Imfinzi to patients as quickly as possible.”
In July this year, AstraZeneca closed the acquisition of Amolyt Pharma, a company specialising in treatments for rare endocrine diseases.
AstraZeneca made a $1.05bn payment for all outstanding shares of Amolyt Pharma, free of cash and debt.
The transaction also comprised an upfront payment of $800m and an additional $250m contingent upon reaching a particular regulatory milestone.
