- The FDA's Oncologic Drugs Advisory Committee meets Wednesday to decide if AstraZeneca's (AZN -1.2%) cancer drug olaparib should be given an accelerated approval or wait for the final results of the ongoing SOLO-2 clinical trial. The panel will discuss the results of Study 19 where olaparib demonstrated an 83% reduction in risk of progression or death in patients with ovarian cancer. There appears to be questions regarding the validity and reproducibility of the magnitude of the treatment effect, however. The committee will decide if the treatment benefits outweigh the side effects risk.
- If the panel votes to wait until the completion of the SOLO-2 study, U.S. approval will not happen until 2016 considering the trial's mid-2015 final data collection date.
- The company forecasts olaparib peak sales of $2B which places it in the top six pipeline candidates that it included in its recent investor presentation.