FDA Approves First Drug Under Project Orbis

The FDA has approved a new combination therapy under its new international plan, Project Orbis.

As the first act under Orbis, the FDA has granted accelerated approval to Lenvantinib (Lenvima, Eisai) in combination with pembrolizumab (Keytruda, Merck) 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 an FDA release, the approval is based upon the results from a recent clinical trial comprised of 94 patients with endometrial carcinoma tumors that were not MSI-H or dMMR. Response rate was designated as the disappearance of lesions on imaging. 10.6% of trial patients had a complete response rate, (complete disappearance of all lesions). 27.7% of patients had a partial response rate (lesion shrinkage of at least 30%), which led to an objective response rate of 38.3%. 69% of patients in the clinical trial had a duration of response greater than six months. 

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Adverse events reported throughout the clinical trial include fatigue, high blood pressure, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis. Additional adverse events reported with the use of levantinib include vomiting, decreased weight, abdominal pain, head, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.

According to the FDA, Project Orbis is the new, international partnership between the FDA’s Oncology Center of Excellence, the Australian Therapeutic Good Administration, and Health Canada. The goal of the initiative, according to an FDA release, is to increase collaboration among international regulatory agencies that will allow patients to receive earlier access to new cancer treatment products available in other countries where regulatory submissions may be delayed, regardless of whether or not the product has gained FDA approval. 

"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, MD in a statement. "As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community."

Full Prescribing Informaiton (lenvatinib)   Full Prescribing Informaiton (pembrolizumab)