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September 17, 2019 – Beth Fand Incollingo
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FDA Approves New Drug Combination to Treat Endometrial Cancer
The combination use of Keytruda and Lenvima is now approved to treat a subset of patients with advanced endometrial cancer.
BY Beth Fand Incollingo
PUBLISHED September 17, 2019
The Food and Drug Administration (FDA) has approved a combination of two drugs – Lenvima (lenvatinib) and Keytruda (pembrolizumab) – to treat a subset of patients with advanced endometrial carcinoma.
The targeted drug and immunotherapy received accelerated approval as a treatment for patients whose endometrial cancer is not categorized as microsatellite instability-high or mismatch repair deficient, who are not eligible for curative surgery or radiation, and whose disease has progressed after previous systemic therapy. The approval was based on a study of 94 patients, a little over one-third of whom had a response to the regimen that lasted up to six months.
The decision was made under a new initiative of the FDA Oncology Center of Excellence, known as Project Orbis, which is designed to allow international partners to concurrently submit oncology drugs for review. In addition to the FDA, the Australian Therapeutic Goods Administration and Health Canada collaborated on the review of the combination, leading to simultaneous approvals in all three countries.
“We are pleased to be working alongside our Australian and Canadian colleagues to help make potentially life-changing treatments available to patients as quickly as possible while still ensuring the FDA’s high standards of safety and effectiveness,” acting FDA commissioner, Dr. Ned Sharpless, stated in the press release. “As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community.”
Check back later to learn more about how this approval will affect patients with advanced endometrial cancer.
The targeted drug and immunotherapy received accelerated approval as a treatment for patients whose endometrial cancer is not categorized as microsatellite instability-high or mismatch repair deficient, who are not eligible for curative surgery or radiation, and whose disease has progressed after previous systemic therapy. The approval was based on a study of 94 patients, a little over one-third of whom had a response to the regimen that lasted up to six months.
The decision was made under a new initiative of the FDA Oncology Center of Excellence, known as Project Orbis, which is designed to allow international partners to concurrently submit oncology drugs for review. In addition to the FDA, the Australian Therapeutic Goods Administration and Health Canada collaborated on the review of the combination, leading to simultaneous approvals in all three countries.
“We are pleased to be working alongside our Australian and Canadian colleagues to help make potentially life-changing treatments available to patients as quickly as possible while still ensuring the FDA’s high standards of safety and effectiveness,” acting FDA commissioner, Dr. Ned Sharpless, stated in the press release. “As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community.”
Check back later to learn more about how this approval will affect patients with advanced endometrial cancer.
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