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.
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International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
The UK has streamlined its process for companies to make submissions to the MHRA under Project Orbis, the global initiative to fast-track access to promising cancer drugs.
England’s health technology assessment body, NICE, and the medicines regulator, the MHRA, are “leading the way” in making innovation available to patients and ensuring an efficient and proportionate use of resources, according to BMS.