What does the FDA’s international effort mean?

Yesterday, the FDA made some history: For the first time, it coordinated with foreign health authorities to simultaneously approve a combination of cancer drugs. But before you imagine a streamlined global drug review that would save the industry money and shorten patient wait times, there are a few things to consider.

For one, the simultaneously approved combination consists of two treatments, Merck’s Keytruda and Eisai’s Lenvima, that were already on the market. For two, the FDA’s intercontinental system, called Project Orbis, involves monthly teleconferences with five global drug reviewers, including the European Medicines Agency. The Keytruda-Lenvima decision involved only two, Australia and Canada, suggesting the agency has a ways to go when it comes to convincing other regulators.

All that said, the FDA intends to expand project Orbis to include more territories and, eventually, to consider first-time approvals, not just label expansions. And, as global clinical trials become more uniform, there could come a day when a single application could work for a host of the world’s largest nations.