CAMBRIDGE, Mass. (TheStreet) -- Aveo Oncology (AVEO) shares are down 23% to $5.74 in Tuesday's trading following the release of an FDA review of its kidney cancer drug tivozanib. An FDA advisory panel will be reviewing tivozanib on Thursday.
Frankly, I'm surprised at the ferocity of selling in Aveo this morning. FDA raised concerns about the negative survival data in the tivozanib phase III trial, but investors knew this was going to be a significant issue for the agency and a big debating point during Thursday's panel.
Here's the key voting question for Thursday's tivozanib panel, as proposed by FDA:
Given the uncertainty in overall survival, and availability of multiple therapies, is another trial needed to better characterize the risk:benefit profile of tivozanib before approval can be considered?The suggestion that FDA may want Aveo to conduct a second clinical trial of tivozanib is probably what's freaking out investors most this morning. The scare might be justified. Here's what FDA says about a meeting with Aveo held in May 2012, right before the company submitted tivozanib for approval: A pre-NDA meeting was held in May 2012. Here, the FDA expressed concern about the adverse trend in overall survival in the single phase 3 trial and recommended that the sponsor conduct a second adequately powered randomized trial in a population comparable to that in the U.S. Remember, Aveo only enrolled 40 patients out of 517 in the tivozanib trial from centers in Western Europe and North America. Later in the review, FDA says it's "unclear whether the patients in this study were representative of those in the U.S." FDA's review of tivozanib was only 13 pages long, relatively brief and straightforward. As we knew already, tivozanib demonstrated a statistically significant improvement in progression-free survival over Onyx Pharmaceuticals' (ONXX) Nexavar, but overall survival in the tivozanib arm was shorter than in the Nexavar arm. This PFS-OS conundrum will be the focal point of Thursday's FDA advisory panel. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
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
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV