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Project Orbis enables concurrent regulatory approval of LENVIMA and KEYTRUDA combination therapy in Canada, U.S. and Australia

Authored byChen Li

On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the U.S. Food and Drug Administration (FDA), and the Australian Therapeutic Goods Administration.

The joint decision by all three regulatory authorities was the first of its kind and a direct result of the collaborative review process under Project Orbis, a new initiative of the FDA Oncology Center of Excellence. Project Orbis provides the framework for concurrent submission and review of oncology products among international partners despite regulatory divergence, with the goal of facilitating early patient access to innovative oncology products and promoting greater uniformity in the standards of treatment.

In a news release announcing the first action under Project Orbis, the FDA indicated that other countries in addition to Canada and Australia may be involved in future collaborative reviews.

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