The U.S. Food and Drug Administration (FDA) has approved a new drug for certain adult patients with endometrial cancer.
Jemperli (dostarlimab-gxly), made by British pharmaceutical company GSK, is intended for people with advanced or recurrent primary forms of cancer, according to the FDA's Aug. 1 announcement.
It is an immunotherapy-based drug, which means it uses the body's immune system to attack cancer cells.
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In clinical trialsJemperli showed improved progression-free survival and overall survival for all patients, according to Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Florida.
“This class of drugs has been used in the second-line setting,” Slomovitz said, meaning they were only used if a first-line (primary) treatment was ineffective or had intolerable side effects.
The FDA has approved a new drug for certain adult patients with endometrial cancer. (iStock)
“Move them to the front line [status] “Better results will be achieved here.”
This is the third FDA approval this year for immunotherapy in endometrial cancerthe doctor noted.
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“This is great news for our patients,” Slomovitz told Fox News Digital.
“Endometrial cancer has become the leading cause of death above all other gynecological cancers, including ovarian cancer.”
Jemperli (dostarlimab-gxly), manufactured by British pharmaceutical company GSK, is intended for people with advanced or recurrent primary forms of cancer. (iStock)
Before immunotherapy options became available, the only treatment for endometrial cancer was chemotherapy alone, Slomovitz said.
“These results are game-changing: there is no precedent for obtaining three approvals in such a short period of time.”
The most common side effects of all immunotherapy drugs are gastrointestinal, endocrine and dermatological toxicities, the doctor noted.
“These results are game-changing: there is no precedent for obtaining three approvals in such a short period of time.”
“Patients need to understand that adding immunotherapy to traditional chemotherapy has better outcomes and the toxicity profile is manageable,” he added.
For physicians, Slomovitz stressed the need to adapt quickly and make the newly approved drug a first-line treatment option for their patients.
GlaxoSmithKline (GSK) is the UK-based pharmaceutical company that makes Jemperli. (REUTERS/Dado Ruvic/Illustration/File photo)
In June, the FDA approved Merck's Keytruda (pembrolizumab) for use in combination with chemotherapy for adult patients with advanced or relapsed acute myeloid leukemia. endometrial cancer.
“The Merck trial (pembrolizumab) showed a significant improvement in progression-free survival for all patients,” Slomovitz said.
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That same month, AstraZeneca's Imfinzi (durvalumab) was approved for patients with advanced or recurrent disease who have a certain biomarker.
The AstraZeneca trial also showed improved progression-free survival for all patients.
All the tests for the new cancer drugs They were conducted through the GOG Foundation, which is the largest cooperative group for all gynecologic oncology research, Slomovitz noted.
“The addition of immunotherapy to chemotherapy provided an improvement in survival outcomes without a negative impact on quality of life,” said one oncologist. (iStock)
In trials, using immunotherapy drugs in combination with chemotherapy reduced the risk of disease progression by about 70% in patients whose tumors had certain biomarkers.
In other patients without that biomarker, there was still a “clinically and statistically significant improvement in time to progression, which is meaningful for our patients and has now led to FDA approvals in both biomarker settings,” Dr. Kathleen N. Moore, co-director of the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, told Fox News Digital.
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“These studies have transformed outcomes for patients with endometrial cancer and are poised to change the Treatment overview to improve the future,” he added.
Shannon N. Westin, MD, medical director of the Gynecologic Oncology Center at the University of Texas MD Anderson Cancer Center, said she is “thrilled” to have multiple new options for patients with advanced and recurrent endometrial cancer after years without new therapies.
This is the third FDA approval this year for immunotherapy in endometrial cancer, the doctor noted. “It's great news for our patients,” one oncologist told Fox News Digital. (iStock)
“We no longer have to treat everyone the same, and instead we can employ precision medicine to improve the survival of these survivors.”
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“The addition of immunotherapy to chemotherapy provided an improvement in survival outcomes without a negative impact on quality of life,” She continued.
“This is the ideal scenario.”
Fox News Digital has reached out to GSK for comment.
