Recent FDA actions have significantly expanded treatment options for women with advanced uterine cancer, according to two oncologists with Regional Cancer Care Associates (RCCA), one of the nation’s largest networks of cancer specialists.
“Since April, the FDA has approved two therapies for women whose endometrial cancer has progressed despite earlier treatment. The approvals enhance RCCA’s ability to deliver cutting-edge therapies to patients in a community-based setting and to formulate a highly individualized treatment strategy for each woman,” says Iuliana Shapira, MD, RCCA’s Chief Medical Officer.
Dr. Shapira explains that on April 22, the FDA granted accelerated approval to a medication called dostarlimab-gxly (JEMPERLI™, GlaxoSmithKline) to treat recurrent or advanced endometrial cancer associated with deficiencies in the body’s process for repairing mistakes in copying DNA during cell division. The FDA’s approval, or indication, is limited to use in women who have had disease progression despite treatment with a platinum-containing chemotherapy regimen. Further, to be eligible for the intravenously-administered medication, a test must confirm that a woman has the DNA-copying problem, which is known as deficient mismatch repair, or dMMR.
The board-certified medical oncologist and hematologist adds that on July 21, the FDA approved the combination of pembrolizumab (Keytruda®, Merck) and lenvatinib (Lenvima®, Eisai) to treat advanced endometrial carcinoma in women whose disease is not associated with dMMR or another DNA-related condition called microsatellite instability-high. The FDA approval for the combination treatment also specifies that patients must have disease progression following prior systemic therapy and not be candidates for curative surgery or radiation.
“These FDA approvals underscore three important trends in our treatment of endometrial, or uterine, cancer and, indeed, of all cancers,” says Rachel Levenbach, MD, a board-certified medical oncologist and hematologist who practices at the Moorestown, NJ office of RCCA. “First, they both focus on women whose disease has progressed despite earlier treatment. This reflects our increasing ability to offer effective care – and hope – to people with advanced forms of cancer. Second, dostarlimab-gxly is just one of many agents that target cancers driven by a specific genetic mutation or issue, in this case a problem with repairing mistakes in copying DNA. Our increasing understanding of the genetic basis of cancer is enabling us to develop whole new classes of therapies. Third, the FDA approval of pembrolizumab, a type of drug known as a checkpoint inhibitor, for use with lenvatinib, which belongs to another class of drug called kinase inhibitors, highlights the progress we are making in combining different types of agents to offer patients increased benefit.”
Dr. Levenbach continues, “The National Cancer Institute estimates that there will be roughly 66,500 new cases of uterine cancer diagnosed in the United States this year, and that 12,940 women across America will die from the disease in 2021. Further, the rate of uterine cancer has risen slightly in recent years, so it is important that we expand our treatment options for women. I’m proud that my RCCA colleagues and I are able to offer our patients both the full range of available therapies — including just-approved treatments – and access to clinical trials.”
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Drs. Shapira and Levenbach are among RCCA’s 80+ cancer specialists. Those oncology specialists treat patients at more than 20 RCCA care centers in New Jersey, Connecticut, Maryland, and the Washington, DC, area. Those oncologists see more than 22,000 new patients each year and provide care to more than 225,000 established patients, collaborating closely with their patients’ other physicians. They offer patients the latest in cutting-edge treatments, including immunotherapies and targeted therapy, as well as access to a wide range of clinical trials. In addition to serving patients who have solid tumors, blood-based cancers, and benign blood disorders such as anemia, RCCA care centers also provide infusion services to people with a number of non-oncologic conditions —including multiple sclerosis, Crohn’s disease, asthma, and rheumatoid arthritis—who take intravenously-administered medications.
To learn more about RCCA, call 844-928-0089 or visit RCCA.com.