FDA Approves First Cancer Drugs in Collaboration With TGA and Health Canada

The FDA announced its first joint approval for oncology drugs with regulators in Australia and Canada under an initiative called Project Orbis, granting accelerated approval for a combination treatment for advanced endometrial cancer.

The agency granted accelerated approval for Eisai’s Lenvima (lenvatinib) in combination with Merck’s Keytruda (pembrolizumab) for certain patients with advanced endometrial cancer who have disease progression following systemic therapy but are not candidates for surgery or radiation.

Approval of the combination treatment was based on the results of a clinical trial of 94 patients. Ten patients had a complete response, or disappearance of all lesions, and 26 had a partial response, with a shrinkage of lesions by at least 30 percent.