Merck & Co. Inc. and Eisai Co. Ltd. won approval of a combination of their drugs Keytruda and Lenvima to treat endometrial carcinoma in three countries at once: the U.S., Australia and Canada.
The approval marks the first action under a new collaboration between regulatory bodies in the three countries for simultaneous review of cancer therapies. Participating in the new program, called Project Orbis, is the U.S. Food and Drug Administration, the Australian Therapeutic Goods Administration and Health Canada.
In the U.S., the accelerated approval allows the drug combination to be marketed for endometrial cancer, but Merck and Eisai must still provide additional data to the FDA.
The agencies reached approval three months prior to the FDA's original goal, a timeframe that Richard Pazdur, director of the FDA's Oncology Center of Excellence, attributed to the three bodies working together along with a "Real-Time Oncology Review," or RTOR, process that he said streamlined data submission.
"RTOR, and its accompanying Assessment Aid, facilitated discussions among the regulatory agencies, expediting the approval in the three countries," Pazdur said in a Sept. 17 release. Assessment Aid is a pilot program that allows applicants to voluntarily submit a form that offers earlier information about a trial.
The collaboration among the regulatory agencies was established to allow access to cancer treatments earlier than might otherwise be possible due to delays in submission and different standards of care, the FDA said. The framework lets the regulators work together to avoid redundancies and facilitate a faster approval.
"As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community," Acting FDA Commissioner Ned Sharpless said.
