Cellular advances in the field of immunotherapy such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocytes are generating great interest in oncology even as scientists, manufacturers, and regulators grapple with the challenges of bringing them to the clinic. To address key issues and obstacles inherent in designing cell therapies for the future,…
The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age. According to Scott Gottlieb, MD,…
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 companion diagnostic development for new tissue-agnostic cancer treatments may raise concerns about patient access. Richard Schilsky, American Society of Clinical Oncology senior VP and…
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 expand an oncology therapy to a tissue-agnostic indication, but a US Food and Drug Administration official warned that the data also…
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 tissue-agnostic indication despite failing to show a response in one tumor type as the US Food and Drug Administration intends to remain flexible with its approval requirements. …
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 anything, I would have wanted to have been the president that ended cancer, because it’s…
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) requirements in biological license applications. An agency official acknowledged that the difficulties in manufacturing these products demand such flexibility, which will make it easier to move them from…
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 are matched with a treatment approach based on the genomic insights from his or her individual tumor profile, the outcomes can be significant. Single biomarkers, typically…
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. The study is the result of a joint project between ASCO and the nonprofit advocacy group Friends of Cancer Research, which issued recommendations…
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 primary purposes of eligibility criteria are designed to protect the safety of patients participating in a clinical trial and to define the trial population, excessive or…
