Dual Approval For Verzenio Under International Review Scheme
The joint review by Australia and Canada of the metastatic breast cancer drug, Verzenio, helped regulators in both jurisdictions achieve efficiencies.
You may also be interested in...
Xofluza is also the first non-cancer drug to be reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing initiative.
Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.
Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.