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

Regulatory Focus – 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.


The collaboration was launched in September with an FDA, Australia’s Therapeutic Goods Administration (TGA) and Health Canada decision to grant accelerated (or conditional) approval to a new indication for Eisai’s Lenvima (lenvatinib) in combination with Merck’s Keytruda (pembrolizumab). The approval was also part of FDA’s real-time oncology review pilot program.


And although all three regulators agreed on this conditional/accelerated approval, Pazdur explained Tuesday that none of the countries have to accept the same decision as the others. “This is not a process of consensus. If a country wanted to take a different opinion, they’re free to do so, and likewise labeling is different,” Pazdur said.


Health Canada officials explained how their review process was accelerated by the pilot, noting that a typical new indication under a conditional approval has a 200-day review period, whereas this application was reviewed in 90 days.


Pazdur also explained how the TGA found the FDA’s reviews to be basically useless because they were so heavily redacted. But the agency worked with sponsors to allow for some unredacted reviews.


“There were some companies that did not want to participate,” Pazdur said of his conversations with industry, noting that they said they did not have enough manufactured product, or that they did not have a regulatory component in one of the countries or, perhaps because of pricing, he said, as Canada and Australia benchmark their prices on EU prices.


For companies thinking of submitting to Project Orbis, Pazdur added that the pilot “does not slow FDA down,” and “we’re not farming out the work to another agency.”


He also noted that another pilot project is coming, to be known as “project point counterpoint,” and which will be aimed at review documents for its Oncologic Drugs Advisory Committee. The pilot will compare FDA’s and the sponsor’s views and their interpretations and evaluations of the data, he said.


And he said the newly renamed Office of Oncologic Diseases should be referred to as “Double-O-D,” with the tag line: “license to cure.”…