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June 19, 2019
The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were... Read more
June 17, 2019
Executive Summary Agency officials and oncologists debate considerations where a data package overwhelms non-responders in favor of a tissue-agnostic indication. Sponsors may be able to obtain a... Read more
June 17, 2019
Executive Summary ASCO official argues postmarket development of diagnostics may restrict patient use once added to the label.   Stakeholders are warning the US Food and Drug Administration that slow... Read more
June 17, 2019
Executive Summary The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away. Sponsors may be able to use real-world data to... Read more
June 17, 2019
Joe Biden promised last week that if he is elected to the Oval Office, "we're gonna cure cancer."   It was definitive in a way that the statement he made as vice president in 2015 — “If I could be... Read more
June 12, 2019
The US Food and Drug Administration is willing to grant regulatory flexibility for manufacturers of cell and gene therapy products from certain chemistry, manufacturing and controls (CMC)... Read more
June 6, 2019
Targeted cancer treatments, especially immunotherapies, are complex. Understanding in which patients they will work, and just as importantly in which they won’t, is not easy. However, when patients... Read more
June 5, 2019
Restrictive eligibility criteria may limit or even jeopardize data generalizability of the trial results and opportunities for patients to participate in a clinical trial. [1][2]   And while the... Read more
June 5, 2019
The use of expanded eligibility criteria would allow nearly twice as many people with non-small cell lung cancer to participate in clinical trials, according to data presented at ASCO Annual Meeting... Read more
June 4, 2019
The results of a study led by physicians at Fred Hutchinson Cancer Research Center showed that patients living with HIV and one of a variety of potentially deadly cancers could be safely treated with... Read more