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Orbis clinical trial12/30/2023 Seagen's tucatinib (Tukysa), which the FDA approved last year in combination with trastuzumab (Genentech's Herceptin) and capecitabine for HER2-positive, metastatic breast cancer, is an example of a precision oncology drug that regulators in the US, Switzerland, Singapore, Australia, and Canada collaboratively reviewed within Project Orbis.ĭuring the second session of the American Association for Cancer Research's annual meeting last month, Richard Pazdur, director of the FDA's Oncology Center of Excellence, moderated a discussion with the regulatory, academic, and industry experts involved with the tucatinib development program and provided an inside look at how the Project Orbis review process works and the impact it is having. Angelo de Claro, associate director for global clinical sciences at the FDA's Oncology Center of Excellence, told Precision Oncology News last week that 35 of those 38 approved drugs were targeted therapies and 10 were drugs indicated for molecularly defined patient populations. Currently, regulatory authorities in six countries are participating with the FDA in the project: Australia's Therapeutic Goods Administration, Health Canada, Singapore's Health Sciences Authority, Switzerland's Swissmedic, Brazil's Health Regulatory Agency (or Agencia Nacional de Vigilancia Sanitaria), and the UK's Medicines & Healthcare Products Regulatory Agency.įrom June 2019 to June 2020, before the UK's MHRA joined earlier this year, Project Orbis received 60 marketing applications for cancer drugs, and the participating regulatory agencies approved 38 applications. The FDA's Oncology Center of Excellence launched Project Orbis in 2019 as a collaboration between regulators in multiple countries who jointly review cancer drugs with the goal of expediting access to innovative therapeutics globally. NEW YORK – The US Food and Drug Administration's Project Orbis, a pathway through which drugmakers can launch their cancer therapies in different countries in quick succession, is helping other nations gain access to precision oncology treatments months, sometimes years, earlier than they would have otherwise. This article has been updated to note that the company previously known as Seattle Genetics is now called Seagen.
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