• FDA, EMA team up on pediatric oncology drug development template

    In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.   A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans ...
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    FDA calls in adcomm to review six more oncology accelerated approvals

    After drugmakers voluntarily withdrew four indications for their cancer drugs in recent months, the US Food and Drug Administration (FDA) on Thursday said it would convene an advisory committee to review six more oncology indications with accelerated approval after confirmatory trials failed to verify their clinical benefit.   Over the course of three days in April, FDA’s Oncology Drugs Advisory Committee (ODAC) will review six indications for Roche’s Tecentriq (atezol...
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    Industry-wide accelerated approval review yields four withdrawals

    Since late December, four drugmakers have voluntarily withdrawn indications for their cancer drugs amid an industry-wide review of accelerated approvals by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence.   In each of their statements announcing the withdrawals, Bristol Myers Squibb, AstraZeneca, Merck and Roche said the withdrawal decisions were made in consultation with FDA as part of an industry-wide review of accelerated approvals with con...
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    In new pilot, EC probes uneven oncology product launches

    A pilot program launched this month by the European Medicines Agency (EMA) and the European Commission (EC) aims to reduce the time to market launch of certain oncology products by providing the regulator with an “early warning system” for sponsors’ impending marketing plans. The pilot also seeks to aid understanding of the reasons behind uneven launch of some products across European Union (EU) countries.   The project, which is planned to run through August 2022, sup...
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    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
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    OCE year 4: Progress despite a pandemic

    Last year , the Oncology Center for Excellence laid out their vision for the future in the Project 2025 initiative, an ambitious effort to outline the future of cancer drug development and collaborate with stakeholders advance the field of oncology.   While the organization remains committed to Project 2025, they acknowledged efforts in 2020 soon shifted to address the needs of patients with cancer during the COVID-19 pandemic, according to Richard Pazdur, MD, directo...
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    Draft FDA guidance addresses oncology drug cross labeling

    In response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance for how oncology drugs used in combination regimens can be referenced by means of cross-labeling.   "Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety,” said Richard Pazdur, MD, di...
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    Oncology research mid-pandemic: Challenges may bring durable innovation

    Though clinical research in general has been challenged during the COVID-19 pandemic, oncology trials “have several unique considerations due to disease severity, regimen complexity, and acute care requirements” that have caused even greater challenges, US Food and Drug Administration (FDA) officials wrote in a new viewpoint published in JAMA Oncology .   Data integrity issues and “pandemic-induced protocol deviations” are a concern for sponsors and FDA alike, and the...
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    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
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    FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.   FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.   "There are few effectiv...
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    FDA addresses endotoxin levels in investigational cancer treatments

    Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug Administration.   The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally admi...
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    Project Patient Voice a focus of ASCO-FDA workshop

    A day-long workshop co-sponsored by the US Food and Drug Administration (FDA) and the American Society for Clinical Oncology (ASCO) focused on clinical outcome assessments in cancer clinical trials. A key topic of the day’s work was the pilot version of Project Patient Voice , a new attempt to create a flexible, searchable, accurate, and understandable website for members of the public who wish to learn about patient experience data. The website is meant to give patients ...