![]() " is still a growing company and a lot of it just comes down to bandwidth," Walker said during the discussion at the meeting. ![]() However, Pazdur revealed that the company hadn't initially set out to submit registrational data on tucatinib nearly simultaneously to multiple regulatory bodies through Project Orbis and had to "scurry" to do so. Luke Walker, VP of clinical development at Seagen, noted that the 600-patient, registrational HER2CLIMB trial for tucatinib enrolled patients in the US, Canada, Australia, and 11 European countries, including Switzerland. 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. Also, please follow the guidelines of publisher and editors provided below.This article has been updated to note that the company previously known as Seattle Genetics is now called Seagen. The final version includes names and acknowledgments. If a manuscript is accepted, the editors request a file with the final version. The editors attempt to reach a decision within 3 months of the submission of the manuscript. ![]() The author is informed of the decision by email. The review process can result in acceptance, the recommendation of revisions or rejection of the manuscript. by acknowledgments and self-references in footnotes).Īll submissions are subjected to double blind peer review. Please pay attention to the anonymization of your text so that your identity as author cannot be ascertained directly or indirectly (e.g. In initial submissions, the citation rules of the journal do not have to be strictly followed. A manuscript submitted to the journal must be ready for publication, the editors do not accept partial or draft versions. During the review process, manuscripts may not be submitted elsewhere. Submissions must be original articles (no translations) which must not be previously published. Please send manuscript submissions to the editor-in-chief.
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