FDA has approved AstraZeneca Imfinzi (durvalumab) in combination with carboplatin and paclitaxel, followed by single-agent Imfinzi for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
This approval was based on results from the DUO-E clinical trial for durvalumab, offering hope to patients with endometrial cancer, as measured by physician assessment using RECIST v1.1 criteria.
The FDA utilized the Assessment Aid, a voluntary submission from the applicant to aid in the review process of Durvalumab, by emphasizing the importance of reporting any serious adverse events associated with Durvalumab to the FDA’s MedWatch Reporting System.
Additionally, the FDA offered resources for obtaining single-patient investigational new drugs (INDs) for oncology products through OCE’s Project Facilitate.
Durvalumab offered a new, targeted treatment option for women with this aggressive form of the disease, providing hope for improved outcomes.
This action highlighted the FDA’s commitment to advancing the fight against endometrial cancer by approving durvalumab for patients with specific genetic profiles.
Source: FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-chemotherapy-mismatch-repair-deficient-primary-advanced-or-recurrent
