September 17, 2019

September 17, 2019 – The U.S. FDA has announced the first drug approval granted through Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. Through the program, the FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada granted simultaneous approval for Keytruda® (pembrolizumab – Merck) and Lenvima (lenvatinib – Eisai) to be used in combination to treat advanced endometrial carcinoma in certain patients.

Endometrial carcinoma begins in the lining of the uterus, and is one of several forms of endometrial cancer. An estimated 61,880 new cases of uterine cancers will be diagnosed in the United States in 2019. In most cases, endometrial cancers develop in women who are post menopause and over the age of 45. Advanced endometrial cancers have spread outside of the uterus to areas such as the lymph nodes, bladder, lungs, and other internal organs.

In a clinical trial, treatment with Keytruda and Lenvima produced an objective response rate (ORR) of 38.3%. The median duration of response (DOR) had not yet been reached at the time of data cutoff. Sixty-nine percent of responders had response durations ≥6 months at the time of data cutoff. To be eligible for treatment under the new indication, patients must have experienced disease progression following prior systemic therapy and be ineligible for curative surgery or radiation. Patients must also have cancer that is not mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H).

Recommended dosing is 20mg of Lenvima taken by mouth once daily, and 200mg of Keytruda administered via intravenous (IV) infusion over the course of 30 minutes every three weeks.

This is the fourth FDA-approved indication for Lenvima (originally approved in 2015) and the 22nd for Keytruda (originally approved in 2014). Because this indication was reviewed under an accelerated approval pathway, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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