Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program
The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.
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Xofluza is also the first non-cancer drug to be reviewed under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s work-sharing initiative.
The joint review by Australia and Canada of the metastatic breast cancer drug, Verzenio, helped regulators in both jurisdictions achieve efficiencies.
CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.