FDA Approves AstraZeneca’s IMFINZI® (durvalumab) Plus Chemotherapy to Treat Severe Types of Endometrial Cancer

FDA Approves AstraZeneca’s IMFINZI® (durvalumab) Plus Chemotherapy to Treat Severe Types of Endometrial Cancer

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AstraZeneca’s IMFINZI® (durvalumab) plus chemotherapy has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients struggling with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer.

According to the company’s announcement on Monday, June 18, its latest therapy, IMFINZI® (durvalumab), combined with paclitaxel and carboplatin, followed by the latest IMFINZI monotherapy, have been approved based on prespecified exploratory subgroup results analysis in the DUO-E Phase III.

The results, which were published in the Journal of Clinical Oncology in October 2023, showed that administering IMFINZI plus after treating the patient with a combination of carboplatin can minimize the risk of disease advancing to a more severe status or death by 58% in cases of dMMR endometrial cancer compared to using chemotherapy alone.

Endometrial cancer is one of the most common types of cancer in women, ranking fourth in the US, with 66,000 reported cases and about 12,000 deaths. With these devastating impacts, the new therapy could be a game-changer, particularly in the treatment of patients diagnosed with advanced stage, where the survival rate dips to about 20%. However, 80-90% of early-stage patients can live with effective treatments for five years after diagnosis.

Prospects of New Effective Therapies Amidst Rising Cancer Burden

AstraZenica’s therapy approval boosts the hope that pharmaceutical players will develop and test new and effective medications, especially for endometrial cancer. This area has experienced little advancement in the past decades.

According to Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, a combination of immunology and chemotherapy is emerging as a new standard for endometrial cancer care.

He added that the FDA-approved IMFINZI will offer more options for patients suffering from mismatch repair deficient disease.

In February, the World Health Organization (WHO) projected a record-setting increase in cancer cases by 77%, with over 35 million cases expected in 2050— 15 million more than the estimated cases in 2022.

According to WHO, the increasing number of cancer cases can be attributed to population growth, ageing, and increased exposure to risk factors such as air pollution, tobacco, and alcohol.

Based on the DUO-E results, AstraZeneca has already applied for regulatory approval of the new cancer treatment regime, pending approval in the EU, Japan, and many other countries.

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