The U.S. Food and Drug Administration (FDA) has authorized a new medication for specific adult patients with endometrial cancer.
Jemperli (dostarlimab-gxly), developed by British pharmaceutical firm GSK, is designed for individuals with primary advanced or recurrent variations of the cancer, according to the FDA’s announcement on August 1.
As an immunotherapy-based treatment, it utilizes the body’s immune response to combat cancer cells.
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Jemperli demonstrated enhanced progression-free survival and overall survival rates among all participants during clinical trials, 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 category of drugs has been traditionally used in second-line settings,” Slomovitz explained, indicating it was primarily offered when first-line treatment was ineffective or led to unacceptable side effects.
The FDA has authorized a new therapy for specific adult patients with endometrial cancer. (iStock)
“Shifting these treatments to first-line [status] will result in improved outcomes.”
This marks the third immunotherapy approval from the FDA this year for treating endometrial cancer, the physician highlighted.
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“This is excellent news for our patients,” Slomovitz shared with Fox News Digital.
“Endometrial cancer has emerged as the leading cause of death compared to other gynecologic cancers, including ovarian cancer.
Jemperli (dostarlimab-gxly), created by GSK, is targeted at individuals with primary advanced or recurrent forms of this type of cancer. (iStock)
Prior to the availability of immunotherapy options, chemotherapy was the sole treatment for endometrial cancer, he noted.
“These findings are revolutionary — it’s unprecedented to see three approvals in such a brief timeframe.”
The side effects most often associated with immunotherapy medications include gastrointestinal, endocrine, and skin-related toxicities, as observed by the physician.
“These findings are revolutionary — it’s unprecedented to see three approvals in such a brief timeframe.”
“Patients should recognize that combining immunotherapy with standard chemotherapy leads to improved results, and the toxicity profile remains manageable,” he added.
For healthcare providers, Slomovitz stressed the necessity of promptly adapting and implementing the newly approved drug as a primary treatment option for their patients.
GSK (GlaxoSmithKline) is the British pharmaceutical company responsible for producing Jemperli. (REUTERS/Dado Ruvic/Illustration/File Photo)
In June, the FDA authorized Merck’s Keytruda (pembrolizumab) to be employed alongside chemotherapy for adult patients with primary advanced or recurrent endometrial cancer.
“The Merck trial of pembrolizumab showcased a notable enhancement in progression-free survival for all participants,” Slomovitz mentioned.
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In the same month, AstraZeneca’s Imfinzi (durvalumab) received approval for patients with advanced or recurrent disease who exhibit a specific biomarker.
The AstraZeneca study also demonstrated improved progression-free survival for all participants.
All studies related to these new cancer medications were conducted through the GOG Foundation, the largest cooperative organization for gynecologic oncology research, Slomovitz emphasized.
“Integrating immunotherapy with chemotherapy has led to improved survival rates without compromising quality of life,” an oncologist remarked. (iStock)
Utilizing immunotherapy drugs in combination with chemotherapy during trials decreased the risk of disease progression by approximately 70% for patients whose tumors carried specific biomarkers.
For patients lacking that biomarker, there was still a “clinically and statistically meaningful improvement in progression timelines, which is significant for our patients and now facilitates FDA approvals in both biomarker contexts,” stated Kathleen N. Moore, M.D., co-director of the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, in an interview with Fox News Digital.
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“These research findings have significantly transformed outcomes for endometrial cancer patients and are positioned to positively reshape the treatment landscape moving forward,” she added.
Shannon N. Westin, medical director of the Gynecologic Oncology Center at the University of Texas MD Anderson Cancer Center, expressed her enthusiasm for having multiple new options for patients facing advanced and recurrent endometrial cancer after a lengthy period without new therapies.
This represents the third FDA approval this year for immunotherapy targeting endometrial cancer, as noted by the physician: “This is excellent news for our patients,” he remarked to Fox News Digital. (iStock)
“We no longer need to adopt a one-size-fits-all approach; instead, we can now utilize precision medicine to enhance survival rates for these individuals.”
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“The inclusion of immunotherapy alongside chemotherapy has resulted in enhanced survival outcomes without detriment to quality of life,” she concluded.
“This is the ideal scenario.”
Fox News Digital reached out to GSK for their input.
