TGA teams up with FDA and Health Canada on oncology approval

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The TGA has teamed up with the US FDA and Health Canada for Project Orbis, an initiative under which the regulators will concurrently review and simultaneously decide on select oncology therapies. 

“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 Sharples.“

"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.”

The FDA said collaboration between international regulators may allow cancer patients to receive earlier access to new therapies.

"With a framework for concurrent submission and review of oncology drugs, Project Orbis facilitates a collaborative review to identify any regulatory divergence across review teams," it said.

The US regulator said that as part of Project Orbis, in conjunction with decisions by TGA and Health Canada, it granted accelerated approval to Eisai's LENVIMA (lenvatinib) in combination with MSD's 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.

The TGA has provisionally registered the combination via its provisional approval pathway based on objective response rate and duration of response in a single-arm trial. The regulator said the registration for this indication depends on the verification and description of clinical benefit in confirmatory trials.