FDA Approval Brings New Standard of Care for Endometrial Cancer
The U.S. Food and Drug Administration (FDA) has announced an expansion of the use of the drug dostarlimab to include treatment for endometrial cancer, marking a significant advancement in cancer therapy.
Dostarlimab is a monoclonal antibody. It was originally approved for use in combination with chemotherapy for patients with mismatch repair-deficient recurrent or advanced endometrial cancer. The FDA’s recent decision broadens this indication, allowing use in a wider range of endometrial cancer cases.
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapyhttps://t.co/2ZSKPWQh94#OCENewsBurst
— FDA Oncology (@FDAOncology) August 1, 2024
“This FDA approval means there’s a new standard of care across the board,” said Monica Avila, MD, a gynecologic oncologist at Moffitt Cancer Center. “Historically, people with endometrial cancer with mismatch repair intact didn’t have many options. Now there’s no longer any excuse for why anyone shouldn’t be getting a combination of chemotherapy and immunotherapy.”
The drug works by targeting and blocking the PD-1 protein, which helps cancer cells evade the immune system. By inhibiting this protein, dostarlimab enables the body’s immune system to better recognize and attack cancer cells.
“It takes a lot to get a new standard of care in the frontline setting,” Avila said. “Therapy has to be not only good, but great to treat these really advanced cases of disease. To make the leap from the last line of defense to the first is almost unheard of. It speaks to the power of immunotherapy and the combination with chemotherapy.”
This is the second approval of its kind for patients with endometrial cancer. In June, the FDA approved pembrolizumab in combination with chemotherapy.
“It’s been so long since there’s been anything for endometrial cancer,” Avila said. “Now we’re getting two approvals that are changing the standard of care. It’s very exciting.”
According to the American Cancer Society, endometrial cancer starts in the cells of the inner lining of the uterus. This is the most common type of cancer in the uterus. Nearly 68,000 women will be diagnosed with the disease this year. About 13,000 will die from it.
Endometrial carcinomas can be divided into different types based on how the cells look under the microscope. They include:
- Adenocarcinoma
- Uterine carcinosarcoma
- Squamous cell carcinoma
- Small cell carcinoma
- Transitional carcinoma
- Serous carcinoma
The most common symptoms are abnormal vaginal bleeding or discharge that’s getting worse, occurring between periods or happening after menopause.
There are currently no screening guidelines for the disease. Screening tests used for cervical cancer, such as a Pap test or HPV test, aren’t effective tests for endometrial cancer.
