Clovis Lung Cancer Drug Needs More Study, FDA Panel Saysby
Panel votes 12-1 rociletinib needs study before FDA decision
Clinical trial will be complete in second half of 2018
Clovis Oncology Inc. should complete another clinical trial on its experimental drug for a form of lung cancer before U.S. regulators decide whether to approve it, a government advisory panel said Tuesday.
A panel of outside advisers to the Food and Drug Administration voted 12-1 that Clovis should conclude a study of the treatment’s effect on disease progression before the agency determines whether to clear it for sale. The agency is scheduled to decide whether to approve rociletinib by June 28 and will take the panel’s discussion into consideration. Clovis shares fell 12 percent to $13.22 at 2:22 p.m. in New York, after touching $12.25, their lowest price since November, 2012.
The vote delivers another blow to the drug’s chances after FDA staff last week questioned the effectiveness and safety of the drug, rociletinib, compared with available treatments. The phase 3 study the panel wants to see completed is expected to be done in the second half of 2018, Lindsey Rolfe, Clovis’s chief medical officer, said during the panel meeting. There are often three trial phases before a drug is considered for approval, although some treatments, particularly those for cancer, can be approved based on earlier data.
“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” Patrick Mahaffy, the company’s chief executive officer, said in a statement. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”
Such a path may not exist for the drug, Steven Breazzano, an analyst with Piper Jaffray & Co., said Wednesday in a note to clients.
“We do not currently model any rociletinib revenue and believe that halting all development to conserve cash and create optionality for the company may ultimately represent the most constructive path forward,” Breazzano said.
FDA staff’s concerns with the medicine include the risk of fast and irregular heartbeats, a condition known as QTc prolongation. If eventually approved, FDA staff recommended a boxed notification, the agency’s strongest warning, concerning the heart risk.
The Boulder, Colorado-based company is seeking approval for rociletinib to treat patients with non-small cell lung cancer who have a mutation in a gene related to a protein called epidermal growth factor receptor, or EGFR, and who previously have been treated by another therapy that targets the gene.
FDA staff said last week their review found that tumors shrank or disappeared in 23 percent of patients taking 500 milligrams of the tablets and in 32 percent of those taking 625 milligrams. AstraZeneca Plc’s Tagrisso was approved in November for the same condition. In two clinical trials, 57 percent and 61 percent of patients who took Tagrisso had complete or partial reductions in their tumor size, the FDA said when it cleared that drug for sale.
Non-small cell lung cancer is the most common type of lung cancer, representing about 85 percent of cases, according to the American Cancer Society. The advocacy group estimates that in the U.S. about 224,390 new patients will be diagnosed with all forms of lung cancer this year and that about 158,080 will die from the disease.