International work-sharing pilot sees apalutamide approved in Australia and Canada

5 July 2018

Apalutamide is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) that has been evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Chemical Entities Work Sharing Pilot.

The drug is an oral treatment for patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The review also utilized the Therapeutic Goods Administration’s (TGA) new Priority review pathway.

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