The US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and Health Canada (HC) have simultaneously approved a two-drug combination for the treatment of advanced endometrial carcinoma.
The three agencies worked together under the umbrella of Project Orbis, an initiative that allows concurrent submission and review of oncology products among international partners.
The approvals were granted to lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the treatment of patients with advanced endometrial carcinoma. All three approvals were conditional and will require further evidence of efficacy.
The approvals are for patients whose disease is not microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR), who experience disease progression following prior systemic therapy, and who are not candidates for curative surgery or radiotherapy.
Both drugs are indicated for use in multiple other cancers.
Project Orbis is only for supplemental oncology approvals or approvals for new indications for previously approved therapies. It is not for new drug applications.
“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,” acting FDA Commissioner Ned Sharpless said in a press statement.
“This indication was approved via the new provisional approval pathway, based on objective response rate and response duration in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in the confirmatory clinical trials,” a TGA statement said.
A clinical trial of 94 patients with endometrial carcinoma tumors that were not MSI-H or dMMR reported an objective response rate of 38.3%.