FDA's Project Orbis: Trendsetter Or One-Off

With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. The intent of Project Orbis is to provide a structure for collaboration between international regulatory authorities on the evaluation and marketing approval of oncology drugs and this possibility was first manifest by the simultaneous approval by the US FDA, Health Canada (HC), and Australian Therapeutic Goods Administration (TGA) of a combination regimen of two oncology drugs, Lenvima (lenvatinib) and Keytruda (pembrolizumab), for the treatment of advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

The three regulatory authorities involved are to be congratulated for accomplishing this feat for a high profile program where patients are in dire need of the regimen. These two drugs were approved by the accelerated approval pathway in the US using the Real-Time Oncology Review pilot and its accompanying Assessment Aid program and provisional pathway in Australia. The approval was based on tumor response rate and durability of response. Patients were treated with 20 mg lenvatinib orally once daily in combination with 200 mg pembrolizumab intravenously every three weeks until treatment termination due to toxicity or disease progression.

So the question immediately comes to mind as to whether this is the tip of the iceberg for process improvement for future coordinated international regulatory marketing approvals or is this an isolated incident where all the stars were aligned.