In first, cancer drugs simultaneously approved in US, Canada, Australia

In In The News by Barbara Jacoby


  • For the first time, regulators in the U.S., Australia and Canada on Tuesday simultaneously approved two cancer drugs via a project led by the Food and Drug Administration’s oncology center.
  • Merck & Co.’s immunotherapy Keytruda, when paired with Merck and Eisai’s Lenvima, is now cleared to treat certain endometrial tumors, a decision that expands the labels for both drugs and also marks the first regulatory OK for the combination since Merck teamed up with Eisai in 2018.
  • While a milestone for the companies’ collaboration, more notable is the regulatory cooperation which led to the approval. Collaborating under an FDA program dubbed Project Orbis, U.S. regulators worked with officials from the Australian Therapeutic Goods Administration and Health Canada to collaboratively review applications for the two drugs.

Drug approvals often occur in succession, with pharmaceutical companies typically focusing first on top markets like the U.S. and Europe. Each country has different review procedures as well, at times resulting in delays for a drug cleared in, say, the U.S. to arrive elsewhere.

Project Orbis, piloted by the FDA’s Oncology Center of Excellence, is designed to help coordinate cancer drug reviews, allowing for simultaneous approval and, in theory, earlier patient access to new treatments.

Merck and Eisai’s combination of Keytruda (pembrolizumab) and Lenvima (lenvatininb) is the first recipient of a Project Orbis review.

In this case, the FDA worked alongside its counterparts in Canada and Australia but future reviews could involve other international agencies like the European Medicines Agency.

“As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative,” said acting FDA Commissioner Ned Sharpless in a statement.

Approval of Keytruda and Lenvima in endometrial cancer is an expansion of each drug’s label, rather than an initial OK for either drug. In a question-and-answer document posted online, the FDA said future collaborations could involve a New Drug Application or a Biologics License Application but cautioned that those reviews “may be more complex due to proprietary information involved.”

The FDA’s review of Keytruda plus Lenvima also benefited from another FDA pilot project called “Real-Time Oncology Review,” which permits submission of data prior to the completion of an entire clinical application.

Data supporting the drugs’ approval come from clinical study of 94 patients with advanced endometrial carcinoma that were negative for a type of genetic alteration known as MSI-High or mismatch repair deficiency. Tumors shrank in 36 of the 94 study participants following treatment, including 10 who experienced a complete response.

Clearance of the combo was granted on a conditional basis, meaning Merck and Eisai will need to confirm the drugs’ benefit with further study.

As of the end of June, Merck was running 13 studies of Keytruda together with Lenvima across a similar number of tumor types, including kidney and lung cancers. Merck, which owns a sizable advantage in immuno-oncology thanks to Keytruda, teamed up with Eisai in 2018, inking a deal that gives it rights to 50% of gross profits from sales of Lenvima.

All told the deal could be worth as much as $5.8 billion, provided all clinical, regulatory and sales milestones are hit.