KUALA LUMPUR, Sept 23 — Project Orbis, an initiative of the US’s Food and Drugs Administration (FDA) Oncology Center of Excellence (OCE), provides a framework for concurrent submission and review of oncology drugs among its international partners.
Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada worked together to review applications for two oncology drugs, ensuring simultaneous decisions in all three countries.
“As part of Project Orbis, in conjunction with decisions by TGA and Health Canada, the FDA today granted accelerated approval to Eisai/Merck & Co’s Lenvima (lenvatinib) in combination with Merck & Co’s Keytruda (pembrolizumab) for the treatment of patients with 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,” according to Fitch Solutions Macro Research in its newly-published outlook for cancer research.
Each regulator consented to the drug combination under their own drug label formats in the first approval under the landmark project.
“The regulators exchanged drug labels to learn about any potential differences. Only minor differences were noted,” Fitch said.
“In Canada, the approved indication was slightly different than the approved indication in the US and Australia.”
The project will likely not be used for new drugs. Rather, expediting line extensions will be the primary focus.
“The FDA and the other agencies will discuss the possibility of collaborating on NDA or BLA reviews for oncology products, but the process may be more complex due to proprietary information involved.”
But Fitch anticipated that this will not limit the expansion of cancer drugs.
“Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval,” the research firm noted.