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In the News

June 25, 2019
A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the... Read more
June 25, 2019
The immune checkpoint inhibitor Keytruda (pembrolizumab) was found to be a safe treatment for different cancer types among people living with HIV, data from a Phase 1 trial show.   The results are... Read more
June 20, 2019
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... Read more
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The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were...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 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 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 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