Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

Globe With Medicines
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The US-led Project Orbis initiative was used to authorize six new cancer medicines between 1 January and 5 December this year, while nine indication extensions were granted under the scheme. One medicine had its accelerated approval for a label expansion converted to a full marketing authorization.

One of the main aims of Project Orbis, which was established by the Food and Drug Administration in 2019, was to provide a framework for international regulators to concurrently review filings for cancer drugs

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