publication date: Apr. 1, 2016
The Tivozanib Timeline
December 2008, May 2009
End-of-phase II meetings between AVEO Pharmaceuticals Inc. and FDA result in agreement concerning the design of the phase III trial of tivozanib for advanced renal cell carcinoma.
During the December 2008 meeting, the agency and AVEO discuss several study designs and FDA states that “a substantial, robust improvement in PFS that is clinically meaningful and statistically persuasive may be considered for regulatory decision.”
FDA also states that “a statistically significant improvement in OS is not required for regulatory approval, but a pre-specified OS analysis plan is still helpful in the regulatory decision making process.”
In the May 2009 meeting, the agency and AVEO discuss the final phase III protocol. Crossover design is not discussed and is not included in the phase III study itself (a later protocol added the crossover). See the FDA briefing documents for ODAC.
According to clinicaltrials.gov, the study’s estimated completion date—defined as final collection date for primary outcome measure—is December 2011.
June 9, 2011
Ronald DePinho, co-founder of AVEO and member of the company’s board of directors, is named president of MD Anderson Cancer Center. His wife, Lynda Chin, an AVEO co-founder, joins MD Anderson as a senior scientist.
April 16, 2012
AVEO says the TIVO-1 pivotal … Continue reading 42-13 The Tivozanib Timeline
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