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Keytruda/Lenvima combo simultaneously OK'd in U.S., Australia and Canada

|About: Merck & Co., Inc. (MRK)|By:, SA News Editor

The FDA, Australia's Therapeutics Goods Administration (TGA) and Health Canada have all granted accelerated approval for the combination of Merck's (MRK +1.1%) Keytruda (pembrolizumab) and Eisai's (OTCPK:ESALY -2.3%) Lenvima (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and whose cancer has progressed following prior systemic therapy but are not candidates for curative surgery or radiation.

The simultaneous approvals were enabled by concurrent submissions by the sponsors and collaborative reviews by the three regulators under a pilot program of the FDA's Project Orbis, an initiative of the FDA Oncology Center of Excellence aimed at more timely approvals of cancer medicines via a streamlined process.

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