In the course of our discussions with the FDA, the agency has expressed concern regarding the OS trend and has said that it will review the findings at the time of the NDA filing, as well as during the review of the NDA. They're conducting additional analyses to be included in the NDA submission that demonstrate that the OS data from TIVO-1 are consistent with improved clinical outcomes in RCC patients receiving more than one line of therapy, Analyses that we believe, will directly address this issue. We are continuing to work towards submitting the NDA by the end of the third quarter. However, there is a chance that the additional OS analyses may cause the submission to slip into the fourth quarter.
We remain confident in our data supporting tivozanib and first-line RCC and believe that tivozanib represents an important new treatment option for patients with kidney cancer. To further establish the potential for tivozanib, we announced the TAURUS study designed to demonstrate patient preference of tivozanib compared to sunitinib as first-line therapy. We also expect to initiate a breast cancer study with tivozanib later this year.
Let me now pass the call back to Tuan.
Tuan Ha-NgocThanks for that update Bill. Turning to ficlatuzumab. In May, we reported preliminary PFS findings from our exploratory Phase II study, evaluating ficlatuzumab in combination with gefitinib versus gefitinib monotherapy in previously untreated patients with advanced non-small cell lung cancer. The trial did not meet its end point in the overall population. The data is still maturing and more detailed findings on this study has been accepted for our presentation at ESMO in September. We expect to provide additional information regarding our plans in support of further development of ficlatuzumab at that time. Read the rest of this transcript for free on seekingalpha.com
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts