Pembrolizumab Approved for Classical Hodgkin Lymphoma

PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen...
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In Acute Myeloid Leukemia, Measurable Residual Disease Correlates With Survival

Measurable residual disease correlates with disease-free survival and overall survival data for patients with acute myeloid leukemia (AML), according to results of a meta-analysis published today in JAMA Oncology. This finding supports the continued use of measurable residual disease as a surrogate end point in clinical trials. The investigators, led by first author Nicholas Short, MD, Assistant Professor in the Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houst...
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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
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The Changing Standards for FDA Oncology Approvals: Talal Hilal, MD

The FDA approval process is in place to ensure that drugs are safe and effective before they are made available to the public. But do the clinical trials that lead to approval truly ascertain whether a drug is efficacious? Fully two-thirds of anticancer drug clinical trials leading to FDA approvals between 2014 and 2019 had at least one important limitation in trial design: lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and/or use of a...
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FDA Oncology Approvals: Limitations In Clinical Trial Design

Fully two-thirds of anticancer drug clinical trials leading to FDA approvals over the course of a five-year period from 2014 to 2019 had at least one important limitation that could potentially impact the utility of the results, report the authors of an observational study published today in JAMA Internal Medicine. "Clinical trials leading to marketing authorization of anticancer drugs by the US Food and Drug Administration (FDA) are heterogeneous, with varying strengths and weaknesses," write t...
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