(Alliance News) – AstraZeneca PLC said Monday it has obtained new approval in the United States for the cancer treatment Imfinzi, also known as durvalumab, hailing an “important new option” for patients.
The Food & Drug Administration (FDA) has approved a combination treatment of Imfinzi and chemotherapy for people with certain forms of endometrial cancer, a type of uterine cancer.
The forms of cancer affected are repair-deficient advanced endometrial cancer and recurrent endometrial cancer, the Cambridge-based pharmaceutical company said.
The approval is based on results from a phase 3 trial that showed that Imfinzi combined with carboplatin and paclitaxel, followed by Imfinzi monotherapy, reduced the risk of disease progression or death by 58%. , compared to chemotherapy alone.
Endometrial cancer is the fourth most common cancer among women.
“With the incidence and mortality of endometrial cancer expected to continue to increase significantly over the coming decades, it is more important than ever to offer new treatment options to patients as early as possible in their care journey. This approval highlights clear evidence that durvalumab combined with chemotherapy followed by durvalumab monotherapy provides important clinical benefits to endometrial cancer patients with mismatch repair deficiency,” said Shannon Westin , professor of gynecologic oncology and reproductive medicine at the University of Texas MD Anderson Cancer Center, and principal investigator of the trial.
Dave Fredrickson, executive vice president of AstraZeneca’s oncology offering, said: “The treatment of endometrial cancer has seen limited advances in recent decades, and it is critical that we continue to innovate as the burden of this cancer is expected to increase in the future. Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this context, and the approval of Imfinzi offers an important new option for. patients with mismatch repair-deficient disease.
AstraZeneca released results from the Phase III Echo trial on Sunday. They showed that its drug Calquence, used in combination with bendamustine and rituximab, had a clinically meaningful improvement in progression-free survival in patients with untreated mantle cell lymphoma.
AstraZeneca shares were down 0.2% at 12,488.00 pence each on Monday morning in London.
By Tom Budszus, Alliance News Editor
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