Clovis Craters on Lung Cancer Drug-Review Delay
Clovis Oncology (CLVS) - Get Report must submit additional clinical data on its targeted lung cancer drug rociletinib to U.S. regulators, delaying the approval review and putting the company further behind rival AstraZeneca (AZN) - Get Report .
Shares of Clovis tumbled 67% to $33.22 in early Monday trading. AstraZeneca shares are up 4% to $32.53.
The Clovis problem centers on revisions to the tumor-shrinkage responses in lung cancer patients treated with rociletinib in the clinical trial forming the basis for the ongoing review by the U.S. Food and Drug Administration.
In the rush to seek rociletinib's approval, Clovis submitted data based on a mix of unconfirmed and confirmed responses. However, as the data have matured, the confirmed rociletinib response rate is lower than previously thought, Clovis warned Monday.
Clovis now says the confirmed response rates to the 500 mg and 625 mg doses of rociletinib are 28% and 34%, respectively. Those are lower than the response rates previously disclosed by Clovis.
The FDA has asked for additional efficacy data pertaining to these rociletinib doses. Clovis said the new information will be provided to FDA by the end of Monday but that the resubmission might delay the agency's approval timeline. Clovis was hoping to secure rociletinib's approval by March 30, 2016.
Getting rociletinib on the market is a priority for Clovis because AstraZeneca's competing lung cancer drug Tagrisso was approved on Friday, Nov. 13. FDA approved Tagrisso based on a clinical trial demonstrating a 59% overall response rate, so the revised and lowered rociletinib response rate suggests the drug is inferior, adding to Clovis' problems.
Clovis knew about the lower confirmed response rate to rociletnib during the company's third-quarter conference call held Nov. 5. Clovis CEO Pat Mahaffey, speaking on a conference call Monday, defended the company's actions, saying it needed to hear from FDA before making a public announcement.
Both Clovis' rociletinib AstraZeneca's Tagrisso are designed to be effective against non-small cell lung cancer containing a genetic mutation known as T790M, which renders tumors resistant to treatment with drugs like Roche's (RHHBY) Tarceva.
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