FDA Approves Combination of Keytruda & Lenvima For Treatment Of Advanced Uterine Cancer: What Women Need To Know

The Food and Drug Administration (FDA) has just approved a new treatment option for women with advanced uterine cancer. The combination of immunotherapy drugs Keytruda and Lenvima for the disease after initial treatment has failed. Here's what to know.

Published Jul 28, 2021

Shelby Black

New Treatment for Uterine Cancer

  • The Food and Drug Administration (FDA) has recently approved the combination of Keytruda and Lenvima for the treatment of advanced uterine cancer for women whose disease has progressed after initial treatment and are not eligible for surgery.
  • A clinical trial found that the combination therapy reduced the risk of disease progression in women by 44% and increased overall survival as opposed to those just receiving standard chemotherapy.
  • Uterine cancer is a cancer that develops in the lining of the uterus, and most commonly affects post-menopausal women.

The Food and Drug Administration (FDA) has recently approved a new drug combination which could help thousands of women currently battling advanced uterine cancer (also called endometrial cancer). The combination of pembrolizumab (brand name Keytruda) and lenvatinib (brand name Lenvima) could be a game-changer for those whose initial treatment was unsuccessful.

“This approval fills a significant unmet need for the challenging situation faced by patients with recurrent endometrial cancer,” Dr. Stephanie Wethington, a gynecologic oncologist at John Hopkins Medicine, tells SurvivorNet. “This is an exciting event that brings hope, improving upon the treatment options for women with recurrent endometrial cancer.”

The approval is specifically targeted at women battling advanced uterine cancer whose disease has progressed despite initial treatment and who are not eligible for surgery or radiation. The approval was preceded by a clinical trial which enrolled nearly 830 patients with advanced uterine cancer who were given this combination therapy to measure how their progression-free survival was impacted. According to their findings, the combination therapy reduced the risk of disease progression by 44% and increased overall survival as opposed to those just receiving standard chemotherapy.

Related: ‘I Push Forward’: Meagan Good, 39, Who Had a Uterine Cancer Scare Years Ago, Shares Tips for Surviving Life’s Challenges

“The data supporting this approval indicates that the combination of [Keytruda] and Lenvima confers both a progression free and overall survival benefit over standard chemotherapy,” Dr. Wethington says. “While the regimen is not without a risk of side effects, they differ from chemotherapy and can most often be managed with medications or dose reductions without the need to stop therapy.”

Uterine cancer is a cancer that develops in the lining of the uterus and affects nearly 67,000 women in the United States every year, according to the American Cancer Society. Most women diagnosed with this cancer will be post-menopausal, and it’s extremely rare in cases of younger women. Fortunately, uterine cancer is usually treatable if caught early. The initial treatment plan for most cases is surgery, but this newly approved drug combination could be a game-changer for women facing a recurrence or if they are not eligible for surgery.

Dr. Diana English breaks down the risks and symptoms of uterine cancer

Overview of Uterine Cancer

Gynecological cancers can be tricky to detect, but there are signs that if spotted you should consult about with your doctor. One of the most common symptoms that may indicate that uterine cancer has developed is irregular bleeding. This means bleeding in between periods for pre-menopausal women and unexpected bleeding for post-menopausal women.

When assessing your risk for uterine cancer, there are a few factors that can predispose someone to the disease. These risk factors include conditions such as hypertension, diabetes, Polycystic Ovarian Syndrome (a condition which prevents regular periods), obesity, Hyperandrogenism (a condition where someone holds higher levels of male sex hormones) and Lynch Syndrome.

Related: 5 Possible Symptoms That May Indicate Gynecological Cancer

“I think one of the challenges with uterine cancer is that it can also happen in younger patients that have certain conditions that might predispose them to cancer,” Dr. Diana English, a gynecologic oncologist at Stanford Health Care, previously told SurvivorNet. “These patients might not be thinking about this, their primary care providers might not be speaking to them about this.”

For younger women, it’s important to take note of these conditions and consult your doctor if there is a family history of these risk factors. If so, make sure to ask your physician what screening methods are available.

Ovarian cancer survivor Lisa Mitchell on why she encourages women to speak up about their health when recognizing symptoms

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