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In the News

July 12, 2019
The bill, H.R. 913, was introduced in the House of Representatives by Rep. Ben Ray Lujan (D-NM) and Rep. Gus Bilirakis (R-FL). “Clinical trials have tremendous potential to help patients with life-... Read more
July 12, 2019
External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The... Read more
July 10, 2019
Pilot Project Will Provide Novel Analysis in Partnership With 10 Leading Healthcare Research Organizations Friends of Cancer Research (Friends) is launching the next phase of our Real-World Evidence... Read more
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The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were...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 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

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