Thomas Hutson, DO, PharmD, discusses tivozanib for the treatment of advanced renal cell carcinoma (RCC).
Thomas Hutson, DO, PharmD, Director, Genitourinary Oncology Program, Baylor Charles A. Sammons Cancer Center, Professor of Medicine, Texas A&M Health Science Center College of Medicine, Medical Director and Chair, GU Research for US Oncology and McKesson, discusses tivozanib for the treatment of advanced renal cell carcinoma (RCC).
Hutson, at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, says that he was shocked to learn that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 13-1 that the results from the TIVO-1 trial were insufficient to support the approval of the drug.
Hutson says that he has been involved with the development of tivozanib in phase II and phase III trials and served as a principal investigator for a biomarker study with the drug. Hutson notes that he has seen patients benefit from tivozanib and that several of them travelled to the ODAC meeting to support the drug.
Hutson says that he understands the rationale for ODAC's decision based on the survival concern, but he feels this is easily explained by the crossover. Tivozanib is very active, Hutson says, and it would be very unfortunate if the drug did not move forward and into the hands of patients.
Since the 2013 ASCO meeting, the FDA has rejected the new drug application for tivozanib and has recommended an additional clinical trial to address concerns over existing data.