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FDA, Canada, Australia Collaborate On Cancer Drugs Review


The U.S. Food and Drug Administration on Tuesday unveiled a new international collaboration for simultaneous review and approval of cancer drugs along with the agency's Australian and Canadian counterparts.

The simultaneous approval of cancer therapies by the three regulators is intended to accelerate the process of making these new treatments available to patients around the world and also reduce the cost of the drug review process.

The new collaboration, Project Orbis, is an initiative of the FDA Oncology Center of Excellence or OCE. Under this project, the FDA, the Australian Therapeutic Goods Administration or TGA, and Health Canada collaboratively reviewed applications for two cancer drugs, allowing for simultaneous decisions in all three countries.

"We are pleased to be working alongside our Australian and Canadian colleagues to help make potentially life-changing treatments available to patients as quickly as possible while still ensuring the FDA's high standards of safety and effectiveness," said Acting FDA Commissioner Ned Sharpless.

The FDA said it looks forward to welcoming more international partners to collaborate with it under Project Orbis.

Under Project Orbis, the FDA granted accelerated approval to Lenvima or lenvatinib in combination with Keytruda or pembrolizumab for the treatment of patients with advanced endometrial carcinoma.

The FDA approval is in conjunction with decisions by TGA and Health Canada. This is the first approval under Project Orbis.

The approval is for patients with advanced endometrial carconima that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), in patients who had disease progression even after prior systemic therapy, but are not eligible for curative surgery or radiation.

Endometrial cancer is a disease in which cancer cells form in the tissues of the inner lining of the uterus, or endometrium. It is the most common cancer of the female genital tract.

Lenvima, discovered and developed by Eisai, was initially approved by FDA in 2015. Merck's Keytruda was initially approved by the agency in 2014.

In April, Health Canada and Australia's TGA jointly reviewed and approved Eli Lilly's Verzenio or abemacicib for the treatment of metastatic breast cancer. The two regulators also worked together for the approval of Janssen's prostate cancer treatment Apalutamide in July 2018.

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