Nov 28, 2012 - 9:48 am
Posted November 28 2012
AVEO Oncology and Astellas Pharma Inc. said it has received approval from The U.S. Food and Drug Administration for filing the New Drug Application for Tivozanib.
Tivozanib is an investigational compound with proposed indication for the treatment of patients with advanced renal cell carcinoma. The proposed brand name for tivozanib is TIVOPATH, which is a trademark of AVEO Pharmaceuticals, Inc.
The medicine has not yet been approved in any country. The review of the FDA is expected to be completed by July 28, 2013.
The NDA will include results of the global Phase 3 trial, which evaluates the efficacy and safety of tivozanib compared to sorafenib, an approved targeted agent.
Posted From Cancer Compass November 26, 2012
"My husband was diagnosed with Papillary RCC, Stage IV with Metastatis (lungs/torso) on 5/2/11. He had no symptoms except that he was very tired. In June, 2011, he too had a radical nephrectomy. His kidney had a 5" mass on it, and it was also attached to his pancreas & liver. His group of Oncologists at Beth Israel Deaconess Medical Center, Boston, MA were going to originally put him on Sutent (he didn't quality for IL-2 because he has Papillary, not Clear Renal Cell Carcinoma). Then, about 100 people qualified for a clinical trial study drug that he started in January, 2012. The drug he takes is called Tivozanib. We went this way because the oncologists felt that this was a better route than Sutent, as they told us that Sutent eventually stops working. Tivozanib is going to be FDA approved in 2013. This drug has been amazing. It has shrunk 2 areas in his lungs that are being monitored by Torso CT Scans (part of the clinical trial) by 24%. He also has cavities where there was Cancer - that's great. He also has other improvements as well. The only side effect he has had is that when he reaches the 3rd week on the drug (then he goes off for 1 week), his voice gets a bit raspy, and he might have to take Imodium AD once. He has not had to go on high blood pressure meds. as many of the people who take this drug have. So, at this time, his Cancer is stable, no new growth, and he works 40 hrs./wk."
Posted From The Eighth International Kidney Cancer Symposium – Chicago 2012
Tivozanib as First-line Therapy for mRCC, Dr Robert J. Motzer, MSKCC
Dr. Motzer said that Tivozanib is showing efficacy, safety and tolerability. Tivozanib targets VEGFR.
“Most of the currently approved first-line therapies have a PFS of 11 months or less. Safety is a big issue for our patients – they are looking for tolerability and good quality of life (QOL). Tivozanib inhibits VHGFR types 1,2,and 3. It’s a once daily dosing schedule, 3 weeks on 1 week off.It has no interaction with CYP3A4 inhibitors, so it would have been okay for our patients with anxiety disorders. It has good safety characteristics.
TIVO-1: Is a phase 3 study of Tivozanib vs Sorafenib as first-line targeted therapy for mRCC. Tivozanib dwmonstrated 26 mo vs 9-11 PFS for other drugs. After one year the OS = 77% for Tivozanib,81% sorafenib, need longer data. Tivozanib is very safe, Tolerable, should be a candidate for first-line therapy.”
Posted by Dr. Michael Atkins (Georgetown Comprehensive Cancer Center) - The Eighth International Kidney Cancer Symposium – Chicago 2012
“By contrast, in the Tivozanib trial, only 12% of patients needed dose reductions, and 4% discontinued therapy. The most commonly reported side effects of Tivozanib were: High blood pressuse (44%), diarrhea (22%), dysponia (voice problem, 21%), fatigue(18%), weight loss(17%) all of which were mild (grade 1 or 2). The most commonly reported side effects reported for Sorafenib were: hand/Foot synd(54%) of which high blood pressure (34%), diarrhea (32%), hair loss(21%) and weight loss (17%). Hand/foot syndrome was particularly annoying.
We understand the hypertension seems to be a biomarker for action of drug, but it is still hard to manage. Careful management of hypertension is essential to maintain health. Treating hypertension does not affect the effectiveness of the drug.”