April 13, 2016
By Alex Keown, BioSpace.com Breaking News Staff
BOULDER, Colo. – Shares of Clovis Oncology plummeted more than 18 percent Tuesday after a U.S. Food and Drug Administration (FDA) panel recommended against giving the company’s lung cancer drug, rociletinib, an accelerated approval, meaning regulators will have to wait for late-stage trial results before approval.
The FDA is scheduled to look at the trial data on June 28, Clovis said in a statement. If the FDA had approved the accelerated approval, that would have provided the Colorado-based oncology drugmaker the opportunity to conditionally market rociletinib based on existing trial data.
In its ruling, the FDA panel said “existing data on rociletinib did not adequately characterize its benefit-risk profile over current treatments,” Reuters reported. Panel members pointed to AstraZeneca ’s similar lung cancer drug, Tagrisso, which was approved in November as an example of a current drug. Also, panel members expressed uncertainty about the proposed dose of rociletinib, Reuters said.
Patrick Mahaffy, Clovis’ chief executive officer, said in a statement Tuesday that the company would work with the FDA to determine the best past forward. He added the company was disappointed with the outcome, as “we believe in the strength of the data we presented for rociletinib.”
This is the second setback for Clovis’ lung cancer drug. In November, the FDA requested additional efficacy data about its lung cancer treatment. These two setbacks for rociletinib give AstraZeneca’s tagrisso additional time to become cemented with physicians as a treatment option.
Lung cancer is the second most common cancer in the United States, with more than 200,000 new cases each year, with NSCLC accounting for almost 85 percent of lung cancers. While the second most common cancer, lung cancer is the leading cause of cancer-related death.
These two setbacks for rociletinib may be a portent of bad news for that treatment. Roy Buchanan, an analyst with Janney Capital Markets told Reuters he did not expect the drug to win approval by the FDA and would not be surprised if Clovis withdrew its drug approval application.
Piper Jaffray’s Charles Duncan said Clovis’ approval issues only benefit AstraZeneca. Even if rociletinib does win approval, it will become a secondary choice for physicians, he told Reuters.
Analysts have predicted Tagrisso will generate about $3 billion in revenue at its peak. Tagrisso was approved for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer. A month’s treatment is expected to have a price tag of $12,750, which is comparable to other lung treatments such as Pfizer ‘s Xalkori and Novartis ‘s Zykadia.
Not only will it have to compete with Tagrisso, but several other pharmaceutical companies are developing treatments for non-small lung cancer, including Genentech , which has seen its investigational oral medications shrink tumors in clinical trials. In March, the FDA approved Bristol-Myers ’ Opdivo for treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
Shares of Clovis rallied a bit Tuesday afternoon, climbing back to $14.24 per share, but slid in aftermarket trading to $13.82 per share. Clovis stock has lost more than 70 percent of its value since that November setback with rociletinib, when the stock was trading at $99.43 per share.
