A combination of two drugs in endometrial cancer is the first to win approval under a new initiative by international regulatory agencies designed to speed up approvals of cancer drugs.
On Tuesday, the U.S. Food and Drug Administration, Health Canada and Australia’s Therapeutic Goods Administration simultaneously approved Kenilworth, New Jersey-based Merck & Co.’s Keytruda (pembrolizumab) and Tokyo-based Eisai’s Lenvima (lenvatinib), for advanced endometrial carcinoma without a microsatellite instability-high or mismatch repair deficiency biomarker.
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The approval was granted under Project Orbis, whereby all three regulatory agencies collaboratively reviewed the Merck-Eisai application, exchanging their respective labeling for the combination to learn about any potential differences, though only minor ones were found. The FDA granted accelerated approval under its Real-Time Oncology Review pilot program, which is designed to make the review process more efficient. Health Canada gave a conditional approval to the combination, while the TGA gave a provision approval, which are programs analogous to FDA accelerated approval. Both drugs are already approved in all three countries, and the FDA said that Project Orbis will focus mainly on supplemental approvals as approving new drugs would be a more complex process, though the agencies will discuss that possibility as well.
Data used to support the application came from the Phase II trial KEYNOTE-146, a single-arm trial of the combination in 108 patients. Among 94 patients whose tumors did not have the aforementioned MSI-H or dMMR biomarker, the overall response rate was 38.3 percent, including a complete response rate of 10.6 percent. The median duration of response was not reached, though 69 percent of patients who achieved a response had maintained it for at least six months. Permanent discontinuation of treatment due to adverse reactions – which ranged in severity from Grade 1 to Grade 4 – occurred with 21 percent of patients, with gastrointestinal perforation or fistula, muscular weakness and pancreatitis being the most common reactions resulting in discontinuation.
The roots of Project Orbis date back to 2004, when the FDA’s Office of Hematology and Oncology Products starting having confidential teleconferences with agencies overseas, which in addition to Health Canada and the TGA now include the European Medicines Agency, Switzerland’s Swissmedic and Japan’s Pharmaceutical and Medical Devices Agency. Quarterly meetings between the FDA and China’s National Medical Products Administration to discuss issues related to global drug development but not related to specific products have been taking place as well. Although the approval of Keytruda-Lenvima only included the American, Canadian and Australian agencies, others may be involved in future application reviews as well, according to the FDA.
Photo: FDA, Flickr (free of all copyright for use and redistribution without restriction)
