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US, Canada and Australia simultaneously fast-track Keytruda/Lenvima combo for endometrial cancer

Published on 18/09/19 at 10:04am

The FDA has acted under a new initiative in collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, conducting simultaneous review in all three countries to award accelerated approval to the combination of Keytruda (pembrolizumab)and Eisai's Lenvima (lenvatinib) for the treatment of advanced endometrial carcinoma.

Project Orbis, as the initiative is known, “provides a framework for concurrent submission and review of oncology drugs among its international partners”, potentially facilitating earlier access to medicines by overcoming delays in regulatory submissions.

“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,” said Acting FDA Commissioner Dr Ned Sharpless. “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.”

This indication specifically covers cancer that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), in patients who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

The constituent elements of the combo have both previously secured FDA approval alone, with Keytruda approved in 2014 and Lenvima in 2015. Together, they showed a 10.6% complete response rate and a 27.7% partial response rate among 94 patients with endometrial carcinoma tumours that were not MSI-H or dMMR, showing an objective response rate of 38.3%.  

“In addition to the international collaboration with Australia and Canada, this review used the ‘Real-Time Oncology Review’ (RTOR) pilot programme, which can streamline the submission of data prior to the completion and submission of the entire clinical application,” commented Dr Richard Pazdur, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “RTOR, and its accompanying Assessment Aid, facilitated discussions among the regulatory agencies, expediting the approval in the three countries. These applications were approved three months prior to the FDA goal date.”

Endometrial cancer is the most common form of the disease to affect the female genital tract, characterised by the formation of cancer cells in the tissues of the lining of the uterus.

Matt Fellows


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