Astrazeneca’s Imfinzi drug has been approved in the US for use on patients with primary or advanced endometrial cancer.
The Food and Drug Administration (FDA) has issued approval for the drug to be used in addition to chemotherapy as opposed to instead of it.
The green light followed a clinical trial which found the drug reduced the risk of disease progression or death by 58 per cent versus chemotherapy alone.
The approval could represent a significant step change in the treatment of endometrial cancer. Endometrial cancer is the fourth most common cancer among women in the US, with more than 66,000 patients diagnosed and almost 12,000 deaths in 2022.
Caught early, the disease has a high survival rate, but in advanced cases, the chances of survival fall to below 20 per cent.
Similar trials are ongoing in the EU, Japan, and several other countries regarding the drug’s efficacy in treating endometrial cancer. But Astrazeneca has also received regulatory approval for the treatment with other forms of cancer, including gall bladder and bile duct cancer.
Shannon Westin, Professor of Gynecologic Oncology at The University of Texas, and principal investigator of the trial, said: “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.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, Astrazeneca, 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.”
The drug being allowed for use with female patients in the US is the first major product milestone for Astrazeneca since the pharma giant set itself a very ambitious revenue target of $80bn (£63bn) by 2030.
Heralding a “new era of growth,” the company’s CEO, Pascal Soirot—the best-paid CEO of any FTSE 100 firm—committed the firm to launching ten new drugs before 2030.