FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing  Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis 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 collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

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. This is partly due to different standards of care around the world that also have an impact on the increasingly international conduct of cancer clinical trials, potentially slowing the development of anticancer products. With a framework for concurrent submission and review of oncology drugs, Project Orbis facilitates a collaborative review to identify any regulatory divergence across review teams.

As part of Project Orbis, in conjunction with decisions by TGA and Health Canada, the FDA today granted accelerated approval to Lenvima (lenvatinib) in combination with 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.

Common side effects for patients in the clinical trial included fatigue, high blood pressure, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism (underactive thyroid), nausea and stomatitis (inflamed and sore mouth). Additional side effects included vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia (voice difficulty), hemorrhagic events (bleeding), hypomagnesemia (low magnesium levels), palmar-plantar erythrodysesthesia (hand foot syndrome), dyspnea (shortness of breath), cough and rash. Health care professionals should inform females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Lenvima in combination with Keytruda. Women who are pregnant or breastfeeding should not take this combination because it may cause harm to a developing fetus or newborn baby.

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