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Collaborative oncology drugs review initiative announced by FDA

A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.

The US Food and Drug Administration (FDA) has announced Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among its international partners.

Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada have collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

“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 Ned Sharpless, MD.

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.”

Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval.

With a framework for concurrent submission and review of oncology drugs, Project Orbis aims to facilitate a collaborative review to identify any regulatory divergence across review teams.

As part of Project Orbis, in conjunction with decisions by TGA and Health Canada, the FDA has 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.

“In addition to the international collaboration with Australia and Canada, this review used the ‘Real-Time Oncology Review’ (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application,” added Richard Pazdur, MD, 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.”