- Clovis Oncology's stock has been hammered over the last three months, plummeting 80% since the FDA requested more clinical data on its lead candidate rociletinib. Rociletinib, which is orally active, has been in development for treatment of EGFR-mutated non-small cell lung cancer (NSCLC).
- In October 2015, the FDA granted the drug Priority Review while the European Medicine Association (EMA) had put it in its accelerated assessment program. At the same time, AstraZeneca's competing Tagrisso was also in development for treatment for NSCLC.
- In November, there was a major divergence when the FDA approved Tagrisso but declined to approve rociletinib. At that point, the FDA requested additional clinical trial data from Clovis.
Last year, the FDA asked Clovis for more info in order to examine confirmed responses rates versus unconfirmed rates. Based on the latest analysis, response rates to rociletinib among trial subjects is between 28% to 34%, compared with 59% for Tagrisso-treated patients. However, rociletinib demonstrated a longer duration of action.
Now, however, Clovis has gone back to the FDA asking that the agency reconsider its data on rociletinib. On April 12, an FDA committee will convene to determine whether to recommend approval of the candidate, with a final decision from the FDA expected by June 28.
Analysts have estimated that Tagrisso could reach peak sales of $3 billion per year.