International – FDA’s Project Orbis May Expand to Singapore and Switzerland

The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research’s annual meeting in Washington, DC.

If Singapore and Switzerland are added, Pazdur said following visits to both countries, it would further collaborations between the regulators as there’s currently a work-sharing agreement known as the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. Australia and Canada also previously worked together to approve two cancer drugs — Eli Lilly’s Verzenio (abemaciclib) in April for the treatment of metastatic breast cancer and the July 2018 approval for Janssen’s prostate cancer treatment apalutamide.

“There may be many more countries that are involved,” Pazdur said of the current collaboration, dubbed Project Orbis, but he also expressed doubt that the European Medicines Agency would join because the current aim is to specifically target countries that have delays in receiving certain new drug applications…