17th Jun 2024 09:09
(Alliance News) - AstraZeneca PLC on Monday said it secured a new US approval for cancer treatment Imfinzi, also known as durvalumab, hailing an "important new option" for patients.
An Imfinzi plus chemotherapy treatment has been backed by the US Food & Drug Administration for sufferers of some forms of endometrial cancer, a type of womb cancer.
The forms of cancer are repair deficient advanced and recurrent endometrial cancer, the Cambridge-based pharmaceutical company said.
The approval is based on phase 3 trial results which showed Imfinzi plus carboplatin and paclitaxel followed by Imfinzi monotherapy reduced the risk of disease progression or death by 58%, when compared to chemotherapy alone.
Endometrial cancer is the fourth most prevalent cancer in women.
"With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care. This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair deficient endometrial cancer," said Shannon Westin, professor of Gynecologic Oncology & 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: "There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future. Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and the approval of Imfinzi offers an important new option for patients with mismatch repair deficient disease."
AstraZeneca on Sunday had reported results from the Echo phase III trial. It showed that its Calquence drug, when used in combination with bendamustine and rituximab, demonstrated a clinically meaningful improvement in progression-free survival in patients with untreated mantle cell lymphoma.
AstraZeneca shares were 0.2% lower at 12,488.00 pence each on Monday morning in London.
By Tom Budszus, Alliance News slot editor
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