The US Food and Drug Administration (FDA) has partnered with the Australian Therapeutic Goods Administration (TGA) and Health Canada to expedite the approval of oncology therapies.
The collaboration, Project Orbis, offers a framework for simultaneous submission and review of drug applications. It is intended to provide early treatment access to cancer patients.
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As part of the project, the regulators reviewed applications for two cancer drugs and provided a concurrent decision in the US, Australia and Canada.
FDA acting commissioner Ned Sharpless said: “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.
“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.”
Under the project, the FDA granted accelerated approval for Eisai and Merck’s Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination in endometrial carcinoma treatment, in conjunction with the TGA and Health Canada decisions.
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By GlobalDataThe approval covers advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who had disease progression even after previous systemic therapy but are not eligible for curative surgery or radiation.
Discovered and developed by Eisai, Lenvima is a kinase inhibitor first approved in the US in 2015. Merck’s Keytruda is an anti-PD-1 therapy initially approved in 2014.
The approval of the drug combination comes from data from the Phase II Study 111 / KEYNOTE-146 in 108 metastatic endometrial carcinoma patients.
In the 94 patients who had tumours that were not MSI-H or dMMR, the combination achieved a 38.3% objective response rate (ORR), 10.6% complete response rate and a 27.7% partial response rate.
Of these responders, 69% had responses lasting more than six months.
