The experts on Wednesday afternoon's panel will review clinical data on carfilzomib as a treatment for advanced multiple myeloma patients who are no longer responding to currently approved medicines. The FDA is asking the panel to vote on whether or not to recommend the approval of carfilzomib.
Carfilzomib, which will be sold under the brand name Kyprolis, shrank tumors in 22% of multiple myeloma patients but FDA, in its review, questioned whether cardiovascular and lung-related side effects undermine the drug's benefit."Since carfilzomib produced an ORR [overall response rate] of only 22% in the primary efficacy study, it may not provide an advantage over available therapy. FDA is very concerned with the severe toxicities, including deaths that are associated with the use of this agent," FDA stated in its review of the drug. If approved, carfilzomib will compete primarily against currently approved multiple myeloma drugs from Celgene (CELG) and Takeda. Onyx is technically seeking accelerated approval for carfilzomib based on results from a phase II study in which all patients were treated with the drug. If Wednesday's panel and later FDA decide these data are not sufficient to approve the drug, Onyx will fall back on an ongoing and larger phase III study with results expected next year. --Written by Adam Feuerstein in Boston.
>To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: email@example.com. Follow TheStreet on Twitter and become a fan on Facebook.
Select the service that is right for you!COMPARE ALL SERVICES
- $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
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV