ARTICLES BY MARJORIE ZETTLER

• New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

  4/21/2023

  On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.

• FDA’s RTOR Program: Draft Guidance & Insights

  10/4/2022

  First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.

• FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

  4/14/2022

  The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.

• 3 Ways The FDA Is Taking Action On Lack Of Diversity In Cancer Clinical Trials

  3/3/2022

  Beyond issuing guidance documents, what actions has the FDA taken to ensure inclusion of relevant patient populations in cancer clinical trials? And what has been the impact? This article outlines three observations regarding the agency's recent efforts.