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In first, cancer drugs simultaneously approved in US, Canada, Australia

BioPharma Dive | September 18, 2019

In first, cancer drugs simultaneously approved in US, Canada, Australia
Drug approvals often occur in succession, with pharmaceutical companies typically focusing first on top markets like the U.S. and Europe. Each country has different review procedures as well, at times resulting in delays for a drug cleared in, say, the U.S. to arrive elsewhere. Project Orbis, piloted by the FDA's Oncology Center of Excellence, is designed to help coordinate cancer drug reviews, allowing for simultaneous approval and, in theory, earlier patient access to new treatments. Merck and Eisai's combination of Keytruda (pembrolizumab) and Lenvima (lenvatininb) is the first recipient of a Project Orbis review. In this case, the FDA worked alongside its counterparts in Canada and Australia but future reviews could involve other international agencies like the European Medicines Agency. "As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative," said acting FDA Commissioner Ned Sharpless in a statement.  Approval of Keytruda and Lenvima in endometrial cancer is an expansion of each drug's label, rather than an initial OK for either drug. In a question-and-answer document posted online, the FDA said future collaborations could involve a New Drug Application or a Biologics License Application but cautioned that those reviews "may be more complex due to proprietary information involved."
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Sebela Pharmaceuticals® today announced that SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, the first tablet colonoscopy preparation to receive approval from the U.S. Food and Drug Administration (FDA) in over 10 years, is now available in the United States. SUTAB is a sulfate-based tablet colonoscopy preparation that is taken orally in a split-dose administration starting the evening before a colonoscopy. The tablets offer a safe and effective alternative to liquid colonoscopy preparations, which traditionally require consuming large volumes of poor-tasting solution and can often be a barrier to patients' willingness to undergo colonoscopy screening for colorectal cancer. 1 The American Cancer Society and the U.S. Preventive Services Task Force recommend adults undergo screening for colorectal cancer beginning at age 45.2 Colonoscopy is the gold standard detection method for colorectal cancer, a leading cause of cancer-related deaths that can be more effectively treated if caught early through screening.3 Within the last decade, the rate of colonoscopy procedures has increased significantly with approximately 18 million people now screened annually for colorectal cancer. "Alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "With the introduction of SUTAB tablets, we hope to take yet another important step toward removing some of the burden often associated with the preparation process – allowing more patients to feel confident in their choice to undergo a colonoscopy." The FDA approved SUTAB on November 10, 2020. The approval was based on positive Phase 3 clinical trials, which evaluated the safety and efficacy of SUTAB compared to FDA-approved preparations in 941 patients, including a traditional polyethylene glycol and ascorbate preparation (PEG-EA) for bowel cleansing prior to a colonoscopy.4

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Fever is the body’s response to a threat. When some viruses or bacteria try to enter the body, an immune response begins that can include a sharp rise in body temperature. It happens in the flu, upper respiratory infections, common colds and lots of other illnesses.