Project Orbis, an initiative of the FDA’s Oncology Center of Excellence, allows concurrent submission and review of cancer drugs with other countries to make the therapies available to more patients faster.
The FDA said different regulation standards around the world slow down the development of cancer drugs, a problem Project Orbis is trying to solve.
Through Project Orbis, the FDA approved Lenvima in combination with Keytruda, two already FDA-approved cancer drugs, in a collaboration with the Australian Goods Administration and Health Canada. The drug combination was approved simultaneously in all three countries, and the FDA said they plan to work with other countries to approve new drugs in the future.
The FDA also used the Real-Time Oncology Review pilot program to expedite the approval, which allowed them to approve the drug three months before the FDA goal date.
Read the full report here.
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