The FDA on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with the FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai’s Lenvima (lenvatinib) in combination with Merck’s 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. All three regulators said they collaboratively worked to review the application, which allows for simultaneous decisions in all three countries, although the labels in each country will differ. “The aim of this collaborative review was to identify any regulatory divergence across the review teams,” OCE said. Lenvima was initially […]