OBJECTIVE: The unique characteristics of cancer, particularly issues involving the use of surrogate endpoints in clinical trials, present special challenges in the development of cancer drugs. In response, the U.S. Food and Drug Administration (FDA) has partnered with the American Society of Clinical Oncology, the American Association for Cancer Research, and the American Society of Hematology to conduct public workshops evaluating potential endpoints for drug approvals for the most common tumor types. METHODS: A workshop evaluating potential endpoints in ovarian cancer drug research was held in Bethesda, Maryland, in April 2006. Invited experts presented research findings and discussed endpoints in trials of drugs for treatment of Stage III and IV ovarian cancer. RESULTS: The panel responded to specific questions from FDA, discussing use of progression-free survival as a surrogate for overall survival and use of CA-125 levels as an indicator of response. Panel members also addressed endpoints in first-line therapy, second-line and subsequent therapy, and maintenance therapy. CONCLUSION: Expert commentary provided by panel members will inform FDA's draft guidance on clinical endpoints for cancer drug approvals and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to define efficacy standards for drugs used to treat ovarian and other cancers.
OBJECTIVE: The unique characteristics of cancer, particularly issues involving the use of surrogate endpoints in clinical trials, present special challenges in the development of cancer drugs. In response, the U.S. Food and Drug Administration (FDA) has partnered with the American Society of Clinical Oncology, the American Association for Cancer Research, and the American Society of Hematology to conduct public workshops evaluating potential endpoints for drug approvals for the most common tumor types. METHODS: A workshop evaluating potential endpoints in ovarian cancer drug research was held in Bethesda, Maryland, in April 2006. Invited experts presented research findings and discussed endpoints in trials of drugs for treatment of Stage III and IV ovarian cancer. RESULTS: The panel responded to specific questions from FDA, discussing use of progression-free survival as a surrogate for overall survival and use of CA-125 levels as an indicator of response. Panel members also addressed endpoints in first-line therapy, second-line and subsequent therapy, and maintenance therapy. CONCLUSION: Expert commentary provided by panel members will inform FDA's draft guidance on clinical endpoints for cancer drug approvals and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to define efficacy standards for drugs used to treat ovarian and other cancers.
Authors: Emma Das-Gupta; Hildegard Greinix; Ryan Jacobs; Li Zhou; Bipin N Savani; Brian G Engelhardt; Adetola Kassim; Nina Worel; Robert Knobler; Nigel Russell; Madan Jagasia Journal: Haematologica Date: 2014-08-22 Impact factor: 9.941
Authors: Leslie M Randall; Michael W Sill; Robert A Burger; Bradley J Monk; Barbara Buening; Joel I Sorosky Journal: Gynecol Oncol Date: 2011-12-01 Impact factor: 5.482
Authors: A M Oza; V Castonguay; D Tsoref; I Diaz-Padilla; K Karakasis; H Mackay; S Welch; J Weberpals; P Hoskins; M Plante; D Provencher; K Tonkin; A Covens; P Ghatage; J Gregoire; H Hirte; D Miller; B Rosen; J Maroun; M Buyse; C Coens; M F Brady; G C E Stuart Journal: Curr Oncol Date: 2011-10 Impact factor: 3.677
Authors: Kathleen M Schmeler; Saroj Vadhan-Raj; Pedro T Ramirez; Sachin M Apte; Lorenzo Cohen; Roland L Bassett; Revathy B Iyer; Judith K Wolf; Charles L Levenback; David M Gershenson; Ralph S Freedman Journal: Gynecol Oncol Date: 2009-03-04 Impact factor: 5.482