On September 17, the U.S. Food and Drug Administration (FDA) announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE).  Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.

As part of Project Orbis, in conjunction with decisions by the Australian Therapeutic Goods Administration (TGA) and Health Canada, the FDA today granted accelerated approval to Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Collaboration among international regulators through Project Orbis allowed for simultaneous decisions in all three countries.

Read FDA announcement on Project Orbis.

Read more on FDA approval of lenvatinib in combination with pembrolizumab for certain patients with advanced endometrial carcinoma.

Posted 9/17/2019