HQ Team
December 5, 2024: The US regulator has approved AstraZeneca’s drug Imfinzi to treat adults with limited-stage cell lung cancer.
Imfinzi (durvalumab), was approved for US patients for whom the disease had not worsened after receiving chemotherapy and radiation therapy, according to a statement from the Food and Drug Administration.
The drug prevents a tumour’s ability to evade the immune system while boosting the body’s anti-cancer immune response, offering an alternative to chemotherapy.
Efficacy was evaluated in an end-stage trial of 730 patients whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy.
22.5 months median overall survival
“The major efficacy outcome measures were overall survival and progression-free survival assessed by blinded independent central review for the comparison between durvalumab as a single agent” and a dummy drug.
“Durvalumab demonstrated a statistically significant overall survival improvement compared to placebo,” according to the regulator. It also “demonstrated a statistically significant progression-free survival improvement compared to placebo.”
The trial showed an improvement in median overall survival of 22.5 months, said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.
The FDA review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners.
Breakthrough designation
The European Medicines Agency (EMA) was an official observer of this review. “This application was granted priority review and breakthrough designation.”
Small cell lung cancer is a highly aggressive form of lung cancer that recurs and progresses rapidly despite initial response to standard-of-care chemotherapy and radiotherapy.
The prognosis for limited-stage small-cell lung cancer is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.
“Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer,” said Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and international coordinating investigator in the trial.
Under review in the EU, Japan
“This finding represents the first advance for this disease in four decades. The…trial showed 57% of patients were still alive at three years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting.”
Regulatory applications are currently under review in the EU, Japan and several other countries in this indication, the company said in a statement.
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is broadly split into non-small cell lung cancer and small-cell lung cancer, with about 15% of cases classified as the latter.
