AstraZeneca has received the US Food and Drug Administration (FDA) Priority Review for Imfinzi (durvalumab) to treat limited-stage small cell lung cancer (LS-SCLC), whose disease has not progressed after platinum-based concurrent chemoradiotherapy (cCRT).
The US FDA accepted the company’s supplemental Biologics License Application (sBLA), based on the results from the positive Phase 3 ADRIATIC clinical trial.
In the Phase 3 trial, Imfinzi reduced the risk of death by 27%, and reduced the risk of disease progression or death by 24%, compared to placebo.
Around 46% of patients treated with Imfinzi did not experience disease progression for two years compared to 34% treated with placebo.
Imfinzi showed a safety profile that was generally manageable and consistent with the known profile of the drug, with no new safety signals observed.
The US health regulator granted a Prescription Drug User Fee Act date for the regulatory decision, during the fourth quarter of this year.
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.”
The European Commission (EC) approved Lynparza and Imfinzi for patients with mismatch repair proficient (pMMR) disease, after Imfinzi plus chemotherapy as the first-line treatment.
Also, the commission approved Imfinzi plus chemotherapy, followed by Imfinzi alone, for patients with mismatch repair deficient (dMMR) endometrial cancer.
The EC approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on the positive results from the Phase 3 DUO-E clinical trial.
In the study, the Lynparza and Imfinzi regimen reduced the risk of disease progression or death for patients with pMMR disease by 43%, and dMMR disease by 58%, compared to control arm.
DUO-E trial investigator Els Van Nieuwenhuysen said: “This approval is welcome news for patients with advanced or recurrent endometrial cancer in Europe, especially those with mismatch repair proficient disease who have limited options.
“The olaparib and durvalumab as well as the durvalumab regimens now have the potential to improve outcomes for all patients in this setting in Europe, regardless of mismatch repair status.”
