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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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.

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Gannex | December 14, 2020

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Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020

Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP). FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients. “The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”

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Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation

Sebela Pharmaceuticals | January 06, 2021

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Spotlight

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.